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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
This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.
Trial website
https://clinicaltrials.gov/study/NCT00939003
Trial related presentations / publications
van der Heijde D, Sieper J, Maksymowych WP, Lambert RG, Chen S, Hojnik M, Anderson JK, Pangan AL. Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial. Arthritis Res Ther. 2018 Mar 27;20(1):61. doi: 10.1186/s13075-018-1556-5.
van der Heijde D, Sieper J, Maksymowych WP, Brown MA, Lambert RG, Rathmann SS, Pangan AL. Spinal inflammation in the absence of sacroiliac joint inflammation on magnetic resonance imaging in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2014 Mar;66(3):667-73. doi: 10.1002/art.38283.
Sieper J, van der Heijde D, Dougados M, Mease PJ, Maksymowych WP, Brown MA, Arora V, Pangan AL. Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1). Ann Rheum Dis. 2013 Jun;72(6):815-22. doi: 10.1136/annrheumdis-2012-201766. Epub 2012 Jul 7.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00939003