Study of Adalimumab in Subjects with Peripheral Spondyloarthritis

Conditions: Peripheral Spondyloarthritis
MedDRA version: 14.1Level: HLTClassification code 10052775Term: SpondyloarthropathiesSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2009-014567-39-CZ

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the efficacy and safety of adalimumab <br>40 mg given every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open-label safety and efficacy assessments in subjects with non-AS, non-PsA active peripheral spondyloarthritis who have had an inadequate response to = 2 Non-steroidal Anti-inflammatory drugs (NSAIDs), or are intolerant to or have a contraindication for NSAIDs.;Secondary Objective: N/A;Primary end point(s): >= 40% improvement from Baseline in Patient Global Assessment of Disease Activity and Patient Global Assessment of Pain and at least one of the following three criteria: 1) Swollen Joint count and Tender Joint Count 2) Enthesitis Count 3) Dactylitis Count;Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Physician's Global Assessment of Disease Activity VAS<br>BASDAI Score<br>HAQ-S<br>Sf-36 v2 physical component;Timepoint(s) of evaluation of this end point: Week 12