Clinical trial NCT01064856: Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)
Official title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Spondyloarthritis
Keywords: peripheral spondyloarthritis
adalimumab
humira
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open label (OL) safety and efficacy assessments in participants with non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral spondyloarthritis (SpA) who have had an inadequate response to \>= 2 non-steroidal anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for, NSAIDs.


Eligibility criteria: Inclusion Criteria:

* Adult participants who had inadequate response to \>= 2 non-steroidal anti-inflammatories (NSAIDs)
* Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria
* Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit were Negative
* Ability to administer subcutaneous injections
* General good health

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 had put patients at risk for participation
* Female participants who were 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

Primary outcomes:
measure: Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12
timeFrame: Week 12
measure: Number of Participants With Adverse Events
timeFrame: Baseline (day of first study drug administration) through Week 156 plus 70 days
Secondary outcomes:
measure: Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
measure: Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
measure: Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
measure: Change From Baseline in Leeds Enthesitis Index at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
measure: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
measure: Change From Baseline in Dactylitis at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
measure: Change From Baseline in Tender Joint Count (TJC) at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
measure: Change From Baseline in Swollen Joint Count (SJC) at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
timeFrame: Baseline (last measurement prior to first DB dose), Week 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: In-Ho Song, MD
role: STUDY_DIRECTOR
References:
citation: Mease P, Sieper J, Van den Bosch F, Rahman P, Karunaratne PM, Pangan AL. Randomized controlled trial of adalimumab in patients with nonpsoriatic peripheral spondyloarthritis. Arthritis Rheumatol. 2015 Apr;67(4):914-23. doi: 10.1002/art.39008.
citation: Coates LC, Abraham S, Tillett W, Mease PJ, Ramiro S, Wu T, Wang X, Pangan AL, Song IH. Performance and Predictors of Minimal Disease Activity Response in Patients With Peripheral Spondyloarthritis Treated With Adalimumab. Arthritis Care Res (Hoboken). 2022 Feb;74(2):259-267. doi: 10.1002/acr.24442. Epub 2021 Dec 29.
citation: Mease PJ, Van den Bosch F, Sieper J, Xia Y, Pangan AL, Song IH. Performance of 3 Enthesitis Indices in Patients with Peripheral Spondyloarthritis During Treatment with Adalimumab. J Rheumatol. 2017 May;44(5):599-608. doi: 10.3899/jrheum.160387. Epub 2017 Mar 15.
citation: Turina MC, Ramiro S, Baeten DL, Mease P, Paramarta JE, Song IH, Pangan AL, Landewe R. A psychometric analysis of outcome measures in peripheral spondyloarthritis. Ann Rheum Dis. 2016 Jul;75(7):1302-7. doi: 10.1136/annrheumdis-2014-207235. Epub 2015 Aug 5.