Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Peripheral Spondyloarthritis

Treatments: Biological: Adalimumab; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01064856

M10-883

2009-014567-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 4 patient groups, including a placebo group

Double-blind (DB) Adalimumab

Experimental group

Description:

Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.

Treatment:

Biological: Adalimumab

Double-blind Placebo

Placebo Comparator group

Description:

Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.

Treatment:

Biological: Placebo

Double-blind Adalimumab / Open-label Adalimumab

Experimental group

Description:

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.

Treatment:

Biological: Adalimumab

Double-blind Placebo / Open-label Adalimumab

Placebo Comparator group

Description:

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.

Treatment:

Biological: Adalimumab

Biological: Placebo