A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 165
- Primary Endpoint
- Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Double-blind Placebo
Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
Intervention: Placebo (Biological)
Double-blind Placebo / Open-label Adalimumab
Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
Intervention: Placebo (Biological)
Double-blind Placebo / Open-label Adalimumab
Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
Intervention: Adalimumab (Biological)
Double-blind Adalimumab / Open-label Adalimumab
Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
Intervention: Adalimumab (Biological)
Double-blind (DB) Adalimumab
Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
Intervention: Adalimumab (Biological)
Outcomes
Primary Outcomes
Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12
Time Frame: Week 12
Percentage of participants achieving the following composite response at Week 12: \>= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; \>= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA - Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and \>= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.
Number of Participants With Adverse Events
Time Frame: Baseline (day of first study drug administration) through Week 156 plus 70 days
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
Secondary Outcomes
- Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12(Baseline (last measurement prior to first DB dose), Week 12)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12(Baseline (last measurement prior to first DB dose), Week 12)
- Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12(Baseline (last measurement prior to first DB dose), Week 12)
- Change From Baseline in Leeds Enthesitis Index at Week 12(Baseline (last measurement prior to first DB dose), Week 12)
- Change From Baseline in Swollen Joint Count (SJC) at Week 12(Baseline (last measurement prior to first DB dose), Week 12)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12(Baseline (last measurement prior to first DB dose), Week 12)
- Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12(Baseline (last measurement prior to first DB dose), Week 12)
- Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12(Baseline (last measurement prior to first DB dose), Week 12)
- Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12(Baseline (last measurement prior to first DB dose), Week 12)
- Change From Baseline in Dactylitis at Week 12(Baseline (last measurement prior to first DB dose), Week 12)
- Change From Baseline in Tender Joint Count (TJC) at Week 12(Baseline (last measurement prior to first DB dose), Week 12)