Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00422383
Registration number
NCT00422383
Ethics application status
Date submitted
15/01/2007
Date registered
17/01/2007
Date last updated
4/05/2015
Titles & IDs
Public title
A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)
Query!
Scientific title
A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.
Query!
Secondary ID [1]
0
0
WA17044
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - rituximab [MabThera/Rituxan]
Treatment: Drugs - rituximab [MabThera/Rituxan]
Treatment: Drugs - rituximab [MabThera/Rituxan]
Experimental: 1 -
Experimental: 2 -
Experimental: 3 -
Treatment: Drugs: rituximab [MabThera/Rituxan]
500mg iv in days 1 and 15, and 500mg iv on days 168 and 182
Treatment: Drugs: rituximab [MabThera/Rituxan]
500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182
Treatment: Drugs: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20)
Query!
Assessment method [1]
0
0
ACR20 defined as overall score of =20 in ACR number (ACRn) calculation. Overall score defined as lowest percent improvement from baseline (BL) of following 3 measures: tender joint count (TJC; 68 joints), swollen joint count (SJC: 66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain (visual analog assessment \[VAS\]), Health Assessment Questionnaire (HAQ), and C-Reactive Protein (CRP). If CRP missing, erythrocyte sedimentation rate (ESR) was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. Last observation carried forward (LOCF) for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR20 set to Non-Responder if ACRn missing
Query!
Timepoint [1]
0
0
Week 48
Query!
Secondary outcome [1]
0
0
Percentage of Participants With ACR 50% Improvement Criteria (ACR50) Response at Week 48
Query!
Assessment method [1]
0
0
ACR50 was defined as an overall score of 50 in the ACRn calculation. Overall score defined as lowest percent improvement from BL of following 3 measures: TJC (68 joints), SJC (66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain (VAS), HAQ, and CRP. If CRP missing, ESR was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. LOCF for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR50 set to Non-Responder if ACRn missing.
Query!
Timepoint [1]
0
0
Week 48
Query!
Secondary outcome [2]
0
0
Percentage of Participants With a ACR 70% Improvement Criteria (ACR70) Response at Week 48
Query!
Assessment method [2]
0
0
ACR70 was defined as an overall score of 70 in the ACRn calculation. The Overall score defined as lowest percent improvement from BL of following 3 measures: TJC (68 joints), SJC (66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain (VAS), HAQ, and CRP. If CRP missing, ESR was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. LOCF for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR70 set to Non-Responder if ACRn missing.
Query!
Timepoint [2]
0
0
Week 48
Query!
Secondary outcome [3]
0
0
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR): Adjusted Mean Change From BL at Week 48
Query!
Assessment method [3]
0
0
DAS28 was calculated according to the following formula: DAS28 equals (=) \[0.56 multiplied by (\*) the square root (v) of TJC\] plus (+) \[0.28 \* v of SJC\] + (0.70 \* the natural logarithm (ln) ESR in millimeters per hour (mm/h)\] + \[0.014 \* participant's global assessment of disease activity (GH)\]. DAS28-ESR = 5.1 = high disease activity, DAS28-ESR less than or equal to (=) 3.2 = low disease activity, DAS28-ESR less than (\<) 2.6 = remission.
Query!
Timepoint [3]
0
0
BL, Week 48
Query!
Secondary outcome [4]
0
0
Percentage of Participants With a Response at Week 48 by European League Against Rheumatism (EULAR) Category
Query!
Assessment method [4]
0
0
EULAR responses were categorized according to DAS28-ESR score. DAS28-ESR = 3.2 at Week 48 and a change from BL to Week 48 \< -1.2 = good response, DAS28-ESR = 3.2 or greater than (\>) 3.2 and = 5.1 at Week 48 and a change from BL to Week 48 \< -0.6 and = -1.2 = moderate response, DAS28-ESR \> 3.2 and = 5.1 at Week 48 and a change from BL to Week 48 \< -1.2 = moderate response, DAS28-ESR \> 5.1 at Week 48 and a change from BL to Week 48 \< -1.2 = moderate response, DAS28-ESR = 3.2 or \> 3.2 and = 5.1 at Week 48 and a change from BL to Week 48 = -0.6 = no response, DAS28-ESR \> 5.1 at Week 48 and a change from BL to Week 48 \< -0.6 and = -1.2 or = -0.6 = no response.
Query!
Timepoint [4]
0
0
Week 48
Query!
Secondary outcome [5]
0
0
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score From BL at Week 48
Query!
Assessment method [5]
0
0
FACIT-F scores were obtained from a 13 question self-administered participant questionnaire designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants responded to the questions using a value between 0 and 4, where 0 indicated "not at all" and 4 indicated "very much." 11 of the 13 questions were negatively stated; indicating the higher the score of the participant's response, the greater their fatigue. These questions were calculated as 4 minus the participants' response, so that a higher score indicated an improvement in health. The scores for the 2 positively stated questions were not changed. The participants' responses were summed to result in an overall score, which are scored 0 to 52 (52 = highest level of functioning). A positive change from BL indicated improvement.
Query!
Timepoint [5]
0
0
BL, Week 48
Query!
Secondary outcome [6]
0
0
Short-Form 36 Health Survey (SF-36) Score
Query!
Assessment method [6]
0
0
SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.
Query!
Timepoint [6]
0
0
BL, Week (Wk) 24 and 48
Query!
Secondary outcome [7]
0
0
Change in SF-36 Score From BL
Query!
Assessment method [7]
0
0
SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.
Query!
Timepoint [7]
0
0
BL, Weeks 24 and 48
Query!
Secondary outcome [8]
0
0
Maximum Observed Serum Concentrations Following the 1st Infusion of Rituximab (Cfirst) in the 1st and 2nd Courses of Treatment in Micrograms Per mL (µg/mL)
Query!
Assessment method [8]
0
0
Cfirst values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.
Query!
Timepoint [8]
0
0
Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).
Query!
Secondary outcome [9]
0
0
Maximum Observed Serum Concentrations Following the 2nd Infusion of Rituximab (Csecond) in the 1st and 2nd Courses of Treatment in µg/mL
Query!
Assessment method [9]
0
0
Csecond values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.
Query!
Timepoint [9]
0
0
Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).
Query!
Secondary outcome [10]
0
0
Terminal Elimination Half-Life (t1/2) in the 1st and 2nd Courses of Treatment in Days
Query!
Assessment method [10]
0
0
t1/2 values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.
Query!
Timepoint [10]
0
0
Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).
Query!
Secondary outcome [11]
0
0
Peripheral Cluster of Differentiation (CD) 19 Positive (+) B Cell Count at BL in Cells Per Microliter (Cells/µL)
Query!
Assessment method [11]
0
0
Surface expression of CD19 was assessed by fluorescence-activated cell sorting (FACS) analysis as a marker of absolute B lymphocyte count.
Query!
Timepoint [11]
0
0
BL
Query!
Secondary outcome [12]
0
0
Percentage of Participants With Peripheral CD19+ B Cell Counts Above BL or the Lower Limit of Normal (LLN)
Query!
Assessment method [12]
0
0
Surface expression of CD19 was assessed by FACS analysis as a marker of absolute B lymphocyte count. The LLN was defined as \< 80 cells/µL.
Query!
Timepoint [12]
0
0
BL, Days 1 and 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [13]
0
0
Peripheral CD20+ B Cell Count in Cells/µL
Query!
Assessment method [13]
0
0
Surface expression of CD20 was assessed by FACS analysis as a marker of mature and memory B lymphocyte count.
Query!
Timepoint [13]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [14]
0
0
Peripheral CD22+ B Cell Count in Cells/µL
Query!
Assessment method [14]
0
0
Surface expression of CD22 was assessed by FACS analysis as a marker of mature lymphocyte count.
Query!
Timepoint [14]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [15]
0
0
Peripheral CD19+CD27+ B Cell Count in Cells/µL
Query!
Assessment method [15]
0
0
Simultaneous surface expression of CD19 and CD27 was assessed by FACS analysis as a marker of memory B lymphocyte count.
Query!
Timepoint [15]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [16]
0
0
Peripheral CD19+CD27 Negative (-) B Cell Count in Cells/µL
Query!
Assessment method [16]
0
0
Surface expression of CD19 in the absence of CD27 expression was assessed by FACS analysis as a marker of naive B lymphocyte count.
Query!
Timepoint [16]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [17]
0
0
Peripheral CD3+ T Cell Count in Cells/µL
Query!
Assessment method [17]
0
0
Surface expression of CD3 was assessed by FACS analysis as a marker of absolute T lymphocyte count. The normal range of CD3+ T cells was defined as 723-2737 cells/µL.
Query!
Timepoint [17]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [18]
0
0
Change From BL in Peripheral CD3+ T Cell Count
Query!
Assessment method [18]
0
0
Surface expression of CD3 was assessed by FACS analysis as a marker of absolute T lymphocyte count. The normal range of CD3+ T cells was defined as 723-2737 cells/µL.
Query!
Timepoint [18]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [19]
0
0
Peripheral CD4+ T Cell Count in Cells/µL
Query!
Assessment method [19]
0
0
Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.
Query!
Timepoint [19]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [20]
0
0
Change From BL in Peripheral CD4+ T Cell Count
Query!
Assessment method [20]
0
0
Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.
Query!
Timepoint [20]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [21]
0
0
Peripheral CD8+ T Cell Count in Cells/µL
Query!
Assessment method [21]
0
0
Surface expression of CD8 was assessed by FACS analysis as a marker of cytotoxic T lymphocyte count. The normal range of CD8+ T cells was defined as 220-1129 cells/µL.
Query!
Timepoint [21]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [22]
0
0
Change From BL in Peripheral CD8+ Cell Count
Query!
Assessment method [22]
0
0
Surface expression of CD8 was assessed by FACS analysis as a marker of cytotoxic T lymphocyte count. The normal range of CD8+ T cells was defined as 220-1129 cells/µL.
Query!
Timepoint [22]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [23]
0
0
Peripheral CD16+56+ Natural Killer (NK) Cell Count in Cells/µL
Query!
Assessment method [23]
0
0
Simultaneous surface expression of CD16 and CD56 was assessed by FACS analysis as a marker of NK cell count.
Query!
Timepoint [23]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [24]
0
0
Change From BL in Peripheral CD16+56+ Cell Count
Query!
Assessment method [24]
0
0
Simultaneous surface expression of CD16 and CD56 was assessed by FACS analysis as a marker of NK cell count.
Query!
Timepoint [24]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [25]
0
0
Percentage of Participants With Total Immunoglobin (Ig), IgA, IgG, and IgM Results Below the LLN
Query!
Assessment method [25]
0
0
The LLNs for total Ig, IgA, IgG, and IgM were defined as 6.75 grams per liter (g/L), 0.70 g/L, 65 g/L, and 0.40 g/L, respectively.
Query!
Timepoint [25]
0
0
BL, Weeks 24 and 48
Query!
Secondary outcome [26]
0
0
Percentage of Participants Who Were Rheumatoid Factor (RF) - Seronegative
Query!
Assessment method [26]
0
0
Percentage of participants who were RF seropositive at BL who became RF seronegative over the course of the study. RF seropositive status was defined as RF = 20 international units (IU) per mL. RF seronegative status was defined as RF \< 20 IU/mL.
Query!
Timepoint [26]
0
0
BL, Weeks 8, 24, and 48
Query!
Secondary outcome [27]
0
0
Anti-Cyclic Citrullinated Peptide (CCP) Antibody Titers at BL in Units Per mL (U/mL)
Query!
Assessment method [27]
0
0
Query!
Timepoint [27]
0
0
BL
Query!
Secondary outcome [28]
0
0
Change From BL in Anti-CCP Antibody Titers in U/mL
Query!
Assessment method [28]
0
0
Query!
Timepoint [28]
0
0
Weeks 8, 24, and 48
Query!
Secondary outcome [29]
0
0
Percentage of Participants With Complement Component 3 (C3) Protein Level = LLN
Query!
Assessment method [29]
0
0
The LLN for C3 protein was defined as \<0.9 grams per liter (g/L).
Query!
Timepoint [29]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [30]
0
0
Change From BL in Complement C3 Protein Level in g/L
Query!
Assessment method [30]
0
0
The LLN of C3 protein was defined as \<0.9 g/L.
Query!
Timepoint [30]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [31]
0
0
Change From BL in Activated Complement Component 3a (C3a) Protein Level in g/L
Query!
Assessment method [31]
0
0
Query!
Timepoint [31]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [32]
0
0
Percentage of Participants With Complement Component 4 (C4) Protein Level = LLN
Query!
Assessment method [32]
0
0
The LLN of C4 protein was defined as \< 0.1 g/L.
Query!
Timepoint [32]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [33]
0
0
Change From BL in Complement C4 Protein Level in g/L
Query!
Assessment method [33]
0
0
Query!
Timepoint [33]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [34]
0
0
Change From BL in Activated Complement Component 4a (C4a) Protein Level in g/L
Query!
Assessment method [34]
0
0
Query!
Timepoint [34]
0
0
BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48
Query!
Secondary outcome [35]
0
0
Percentage of Participants With Positive Human Anti-Chimeric Antibody (HACA) Titers
Query!
Assessment method [35]
0
0
A participant was defined as being HACA positive if the HACA serum level was = 5 relative units (RU) per mL and the physician comment read that participant was "immunodepletable with rituximab".
Query!
Timepoint [35]
0
0
BL, Weeks 24 and 48
Query!
Secondary outcome [36]
0
0
Percentage of Participants With a Change From BL by Category in Anti-Nuclear Antibodies (ANA) Titers
Query!
Assessment method [36]
0
0
ANA titers were obtained by the following serum dilution schema: negative = negative, borderline = 1 diluted to (:) 40 or 1:80, and positive = 1:160. The change categories were defined for the change from BL to Weeks 24 and 48 according to this schema. Negative to borderline was defined as any change from negative to borderline as no dilution is given for negative results. Negative to positive was defined as at least a two-fold positive change in dilution from BL. Borderline to negative was defined as any change from borderline to negative as no dilution is given for negative results. Borderline to positive was defined as at least a two-fold positive change in dilution from BL. Positive to borderline was defined as at least a two-fold negative change in dilution from BL. Positive to negative was defined as at least a two-fold negative change in dilution from BL. Unchanged was defined as any difference in dilution less than two-fold.
Query!
Timepoint [36]
0
0
BL, Weeks 24 and 48
Query!
Secondary outcome [37]
0
0
Percentage of Participants With Positive Recall Antigen Antibody Titers
Query!
Assessment method [37]
0
0
A positive titer result to recall antigens was defined as a serum antibody level equal to or above the following protective levels: tetanus toxoid = 0.1 IU/mL, influenza A \> 12 U/mL, influenza B \> 12 U/mL, and streptococcus (S.) pneumococcus = 1.0 mg/L.
Query!
Timepoint [37]
0
0
BL, Weeks 24 and 48
Query!
Eligibility
Key inclusion criteria
* adult patients >=18 years of age;
* RA for >=6 months;
* receiving outpatient treatment;
* inadequate response to methotrexate, having received and tolerated it for >=12 weeks, with a stable dose for >=4 weeks.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
* inflammatory joint disease other than RA, or other systemic autoimmune disorder;
* diagnosis of juvenile arthritis, or RA before the age of 16;
* previous treatment with >1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
378
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
- Coffs Harbour
Query!
Recruitment hospital [2]
0
0
- Sydney
Query!
Recruitment hospital [3]
0
0
- Maroochydore
Query!
Recruitment hospital [4]
0
0
- Southport
Query!
Recruitment hospital [5]
0
0
- Malvern
Query!
Recruitment hospital [6]
0
0
- Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [2]
0
0
2145 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [4]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [5]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [6]
0
0
3168 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Gent
Query!
Country [2]
0
0
Brazil
Query!
State/province [2]
0
0
GO
Query!
Country [3]
0
0
Brazil
Query!
State/province [3]
0
0
SP
Query!
Country [4]
0
0
Canada
Query!
State/province [4]
0
0
British Columbia
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
Manitoba
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Ontario
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Quebec
Query!
Country [8]
0
0
China
Query!
State/province [8]
0
0
Beijing
Query!
Country [9]
0
0
Finland
Query!
State/province [9]
0
0
Oulu
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Bois Guillaume
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Bordeaux
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Dijon
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Le Mans
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Lille
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Montpellier
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Nice
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Paris
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Bad Nauheim
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
Hamburg
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Heidelberg
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Herne
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Köln
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Osnabrück
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Ratingen
Query!
Country [25]
0
0
Hungary
Query!
State/province [25]
0
0
Debrecen
Query!
Country [26]
0
0
Hungary
Query!
State/province [26]
0
0
Eger
Query!
Country [27]
0
0
Italy
Query!
State/province [27]
0
0
Abruzzo
Query!
Country [28]
0
0
Italy
Query!
State/province [28]
0
0
Basilicata
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
Emilia-Romagna
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Liguria
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Lombardia
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Piemonte
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
Sicilia
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Toscana
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Veneto
Query!
Country [36]
0
0
Netherlands
Query!
State/province [36]
0
0
Amsterdam
Query!
Country [37]
0
0
Netherlands
Query!
State/province [37]
0
0
Leiden
Query!
Country [38]
0
0
Netherlands
Query!
State/province [38]
0
0
Nijmegen
Query!
Country [39]
0
0
New Zealand
Query!
State/province [39]
0
0
Auckland City
Query!
Country [40]
0
0
New Zealand
Query!
State/province [40]
0
0
Christchurch
Query!
Country [41]
0
0
New Zealand
Query!
State/province [41]
0
0
Timaru
Query!
Country [42]
0
0
Slovakia
Query!
State/province [42]
0
0
Kosice
Query!
Country [43]
0
0
Slovakia
Query!
State/province [43]
0
0
Piestany
Query!
Country [44]
0
0
South Africa
Query!
State/province [44]
0
0
Cape Town
Query!
Country [45]
0
0
South Africa
Query!
State/province [45]
0
0
Diepkloof
Query!
Country [46]
0
0
South Africa
Query!
State/province [46]
0
0
Pretoria
Query!
Country [47]
0
0
Spain
Query!
State/province [47]
0
0
Asturias
Query!
Country [48]
0
0
Spain
Query!
State/province [48]
0
0
Barcelona
Query!
Country [49]
0
0
Spain
Query!
State/province [49]
0
0
Burgos
Query!
Country [50]
0
0
Spain
Query!
State/province [50]
0
0
Leon
Query!
Country [51]
0
0
Spain
Query!
State/province [51]
0
0
Madrid
Query!
Country [52]
0
0
Spain
Query!
State/province [52]
0
0
Sevilla
Query!
Country [53]
0
0
Taiwan
Query!
State/province [53]
0
0
Kaohsiung
Query!
Country [54]
0
0
Taiwan
Query!
State/province [54]
0
0
Taichung
Query!
Country [55]
0
0
Taiwan
Query!
State/province [55]
0
0
Taoyuan
Query!
Country [56]
0
0
Thailand
Query!
State/province [56]
0
0
Bangkok
Query!
Country [57]
0
0
Thailand
Query!
State/province [57]
0
0
Chiang Mai
Query!
Country [58]
0
0
Thailand
Query!
State/province [58]
0
0
Khon Kaen
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
Barnsley
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
Birmingham
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Cambridge
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
Glasgow
Query!
Country [63]
0
0
United Kingdom
Query!
State/province [63]
0
0
Londonderry
Query!
Country [64]
0
0
United Kingdom
Query!
State/province [64]
0
0
London
Query!
Country [65]
0
0
United Kingdom
Query!
State/province [65]
0
0
Manchester
Query!
Country [66]
0
0
United Kingdom
Query!
State/province [66]
0
0
Middlesborough
Query!
Country [67]
0
0
United Kingdom
Query!
State/province [67]
0
0
Northampton
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
Nottingham
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
Reading
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
Truro
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
Wigan
Query!
Country [72]
0
0
United Kingdom
Query!
State/province [72]
0
0
Wirral
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00422383
Query!
Trial related presentations / publications
Rubbert-Roth A, Tak PP, Zerbini C, Tremblay JL, Carreno L, Armstrong G, Collinson N, Shaw TM; MIRROR Trial Investigators. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III randomized study (MIRROR). Rheumatology (Oxford). 2010 Sep;49(9):1683-93. doi: 10.1093/rheumatology/keq116. Epub 2010 May 12.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00422383
Download to PDF