Study of Adalimumab in Subjects with Peripheral Spondyloarthritis

• Conditions: Peripheral Spondyloarthritis; MedDRA version: 16.1Level: HLTClassification code 10052775Term: SpondyloarthropathiesSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2009-014567-39-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-29
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Adult subjects with inadequate response to >= 2 non-steroidal anti-inflammatories (NSAIDS)
2. Subjects must have current arthritis, or enthesitis or dactylitis PLUS meeting spondyloarthitis clinical criteria
3. Negative purified protein derivative (PPD) test and Chest X-ray performed at Baseline must be negative
4. Ability to administer subcutaneous injections
5. General good health
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 156
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Prior anti-TNF use
2. Psoriasis or Psoriatic Arthritis
3. Fulfillment of modified New York criteria for Ankylosing Spondylitis
4. Recent infection requiring treatment
5. Significant medical events or conditions that may put patients at risk for participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified