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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00939003




Registration number
NCT00939003
Ethics application status
Date submitted
10/07/2009
Date registered
14/07/2009
Date last updated
9/09/2014

Titles & IDs
Public title
Study of Adalimumab in Patients With Axial Spondyloarthritis
Scientific title
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis
Secondary ID [1] 0 0
2009-010643-14
Secondary ID [2] 0 0
M10-791
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Axial Spondyloarthritis 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
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Adalimumab
Treatment: Other - Placebo
Treatment: Other - Open-label Adalimumab

Experimental: Adalimumab -

Placebo comparator: Placebo -

Experimental: Open-label Adalimumab -


Treatment: Other: Adalimumab
40 mg every other week up to Week 12

Treatment: Other: Placebo
Placebo every other week up to Week 12

Treatment: Other: Open-label Adalimumab
40 mg every other week, Week 12 through Week 156
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Number of Participants Achieving ASAS Partial Remission
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Number of Participants Achieving an ASAS5/6 Response
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S)
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Timepoint [7] 0 0
Baseline and Week 12
Secondary outcome [8] 0 0
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Change From Baseline in SPARCC MRI Score for the Spine
Timepoint [9] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
* Adult patients with inadequate response to >/= 1 non-steroidal anti-inflammatory drugs (NSAIDs)
* Chronic back pain with onset < 45 years of age
* Magnetic resonance imaging (MRI) indicating active sacroiliitis or positive human leukocyte antigen-B27 (HLA-B27) blood test in addition to meeting spondyloarthritis clinical criteria
* Negative purified protein derivative (PPD) test and chest x-ray performed at Baseline visit must be negative
* Ability to administer subcutaneous injections
* General good health otherwise
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior anti-tumor necrosis factor (TNF) therapy
* Psoriasis or psoriatic arthritis
* Fulfillment of modified New York criteria for ankylosing spondylitis
* Recent infection requiring treatment
* Significant medical events or conditions that may put patients at risk for participation
* Females who are pregnant or breast-feeding or considering becoming pregnant during the study
* History of cancer, except successfully treated skin cancer
* Recent history of drug or alcohol abuse

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 administering the treatment/s
The people assessing the outcomes
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
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 22342 - Brisbane
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 21223 - Kogarah
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 21222 - Maroochydore
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Belgium
State/province [7] 0 0
Genk
Country [8] 0 0
Belgium
State/province [8] 0 0
Ghent
Country [9] 0 0
Belgium
State/province [9] 0 0
Gilly
Country [10] 0 0
Belgium
State/province [10] 0 0
Merksem
Country [11] 0 0
Canada
State/province [11] 0 0
Edmonton
Country [12] 0 0
Canada
State/province [12] 0 0
Sainte-Foy, Quebec
Country [13] 0 0
Canada
State/province [13] 0 0
St. John's
Country [14] 0 0
Canada
State/province [14] 0 0
Toronto
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Brno
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Pardubice
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Prague 2
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Uherske Hradiste
Country [19] 0 0
France
State/province [19] 0 0
Boulogne Billancourt
Country [20] 0 0
France
State/province [20] 0 0
Chambray-les-Tour
Country [21] 0 0
France
State/province [21] 0 0
Orleans
Country [22] 0 0
France
State/province [22] 0 0
Paris Cedex 14
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Erlangen
Country [25] 0 0
Germany
State/province [25] 0 0
Herne
Country [26] 0 0
Germany
State/province [26] 0 0
Munich
Country [27] 0 0
Netherlands
State/province [27] 0 0
Amsterdam
Country [28] 0 0
Netherlands
State/province [28] 0 0
Leiden
Country [29] 0 0
Spain
State/province [29] 0 0
A Coruna
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Cordoba
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Aileen L Pangan, MD
Address 0 0
AbbVie
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 are available at https://clinicaltrials.gov/study/NCT00939003