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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02186873




Registration number
NCT02186873
Ethics application status
Date submitted
8/07/2014
Date registered
10/07/2014
Date last updated
22/12/2017

Titles & IDs
Public title
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis
Secondary ID [1] 0 0
CNTO148AKS3001
Secondary ID [2] 0 0
CR103795
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Golimumab

Experimental: Treatment Group 1: Placebo then Golimumab - Participants will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52.

Experimental: Treatment Group 2: Golimumab - Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 16, participants will receive a placebo infusion to maintain the blind.


Treatment: Drugs: Placebo
Participants will receive matching placebo.

Treatment: Drugs: Golimumab
Participants will receive 2mg/kg of intravenous infusions of golimumab .
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16
Timepoint [3] 0 0
Baseline and Week 16
Secondary outcome [4] 0 0
Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
Timepoint [4] 0 0
Baseline and Week 16
Secondary outcome [5] 0 0
Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16
Timepoint [5] 0 0
Baseline and Week 16
Secondary outcome [6] 0 0
Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16
Timepoint [7] 0 0
Baseline and Week 16
Secondary outcome [8] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16
Timepoint [8] 0 0
Baseline and Week 16

Eligibility
Key inclusion criteria
* Participants with diagnosis of definite ankylosing spondylitis for at least 3 months based on modified New York radiographic and clinical criteria
* Participants with symptoms of active disease at screening and at baseline
* Participant has either an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAID) over a 4 week period in total with maximal recommended doses of NSAIDs, or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs
* Participants with C- reactive protein (CRP) level of greater than or equal to (>=) 0.3 milligram per deciliter (mg/dL) at screening
* Additional protocol-defined inclusion criteria apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant with other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy
* Pregnant or lactating females
* Participants with chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis
* Participants who had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis, or pyelonephritis), or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent
* Additional protocol-defined exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/10/2016
Sample size
Target
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Maroochydore
Recruitment postcode(s) [1] 0 0
- Maroochydore
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
Newfoundland and Labrador
Country [11] 0 0
Canada
State/province [11] 0 0
Burlington
Country [12] 0 0
Canada
State/province [12] 0 0
Trois-Rivieres
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Doberan
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Erfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Germany
State/province [17] 0 0
Planegg
Country [18] 0 0
Germany
State/province [18] 0 0
Ratingen
Country [19] 0 0
Germany
State/province [19] 0 0
Zerbst
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Ansan
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Daegu
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Gwangju
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seongdong-Gu
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
Mexico
State/province [25] 0 0
Chihuahua
Country [26] 0 0
Poland
State/province [26] 0 0
Bydgoszcz
Country [27] 0 0
Poland
State/province [27] 0 0
Bytom
Country [28] 0 0
Poland
State/province [28] 0 0
Nadarzyn
Country [29] 0 0
Poland
State/province [29] 0 0
Nowa Sól
Country [30] 0 0
Poland
State/province [30] 0 0
Poznan
Country [31] 0 0
Poland
State/province [31] 0 0
Warszawa
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Moscow
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Saint Petersburg
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Saint-Petersburg
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Saratov
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Smolensk
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Tver
Country [38] 0 0
Ukraine
State/province [38] 0 0
Chernihiv
Country [39] 0 0
Ukraine
State/province [39] 0 0
Dnipropetrovsk
Country [40] 0 0
Ukraine
State/province [40] 0 0
Kyiv
Country [41] 0 0
Ukraine
State/province [41] 0 0
Odessa
Country [42] 0 0
Ukraine
State/province [42] 0 0
Vinnytsia
Country [43] 0 0
Ukraine
State/province [43] 0 0
Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 not provided in https://clinicaltrials.gov/study/NCT02186873