Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

Conditions

• Peripheral Spondyloarthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adalimumab — BIOLOGICAL
  Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.
• Placebo — BIOLOGICAL
  Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.

Study Details

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.

Key Dates

Start date

Feb 28, 2010

Status verified

Jul 2021

Primary completion

Aug 31, 2011

Completion

May 31, 2014

Study Design

Enrollment

165 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Double-blind (DB) Adalimumab
  Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
• Placebo Comparator: Double-blind Placebo
  Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
• Experimental: 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.
• Placebo Comparator: 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.

Primary Outcome Measure

Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12 [ Time Frame: Week 12 ]