GO-AHEAD

• Conditions: Active Axial Spondyloarthritis (SpA); Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-000311-34-GB
• Lead Sponsor: Schering-Plough Research Institute, a Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-19
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Each subject must be >18 to <45 years of age.
2. Each subject must have a physician’s diagnosis of active axial SpA with disease duration =5 years, and chronic back pain of = 3 month duration.
3. Each subject must meet either criterion a” or b” as adopted from ASAS classification criteria:
a. Active inflammation on MRI highly suggestive of sacroiliitis associated with spondyloarthropathy (as evidenced by the central reader) and 1 or more of the following spondyloarthritis characteristics OR
b. HLA-B27+ gene and 2 or more of the following spondylarthritis characteristics (not including HLA-B27):
? Inflammatory back pain, defined as having at least 4 out of the 5 following parameters:
?age at onset < 40 years;
?insidious onset;
?improvement with exercise;
?no improvement with rest;
?pain at night (with improvement upon getting up);
? Arthritis diagnosed by a physician;
? Enthesitis diagnosed by a physician;
? Dactylitis diagnosed by a physician;
? Psoriasis diagnosed by a physician;
? History of inflammatory bowel disease (IBD) diagnosed by a physician;
? History of uveitis confirmed by an ophthalmologist;
? Good response to NSAIDs
? Family history for SpA;
? Elevated CRP (> upper limit of normal based on central lab values);
? HLA-B27+ gene;
4. Each subject must show high disease activity at Screening and Baseline of both a total back pain evaluation of =40 mm on a VAS of 0-100 mm and a BASDAI score of = 40 mm.
5. Each subject must have either an inadequate response (as assessed by the investigator) to 30 days of continuous therapy with maximal recommended daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a maximal dose of NSAID therapy for a full 30 days because of intolerance, toxicity, or contraindications to NSAIDs.

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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The subject has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional X-rays (ie, excluding modified New York criteria) based on central reading at Screening.
2. The subject has ever received TNF-a targeted therapy or any biological agents, including but not limited to infliximab, etanercept, adalimumab, alefacept or efalizumab, rituximab, or natalizumab.

Study & Design

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