Recruitment status was Active, not recruiting
Reduction of signs and symptoms in patients with moderate to severely early axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to or do not tolerate NSAID therapy.
Study Objectives:Efficacy –To assess whether patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) will show response when adalimumab is added to the pre-existing or in case of intolerance to NSAID therapy. Response will be measured at week 12 by change of efficacy parameters compared to baseline.Safety – To demonstrate the safety of adalimumab in study patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) in patients who have had an inadequate response to or do not tolerate NSAID therapy.
Drug: Adalimumab 40 mg sc every other week
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Adalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension Phase|
- ASAS 40 at week 12
- ASAS 20, 70·
- BASDAI 20, 50, 70
- BASFI (absolute change from Baseline)
- Mobility examinations: BASMI, Chest Wall Expansion
- DC-ART20 (5 out of 6)
- CRP, ESR
- Quality of Life: SF-36
- Numeric Rating Scale (NRS) – physicians global, patients global, general pain, nocturnal pain
- Enthesitis index (Maastricht scale)
- swollen joint count
- Safety Evaluations: Adverse events, vital signs, physical examination results, and clinical laboratory values.
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||June 2007|
The study is a two center 12-week double-blind, placebo-controlled trial of adalimumab in patients with moderate to severely active axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to who are or intolerant to NSAID therapy. Patients may have been treated in the past with concomitant DMARDs. For these patients a washout period of at least 4 weeks is necessary. If Leflunomide was discontinued, it should be stopped at least 3 months or should be washed out within 4 weeks before study start. Patients who have been treated previously with approved biologics are allowed to enter the study if they failed due to lack of efficacy and/or intolerance. The placebo-controlled treatment period of 12 weeks will be followed by an open-label maintenance therapy up to Week 52. Following screening and baseline evaluations, patients will be assessed at Weeks 2, 4, 8, and 12. During the maintenance therapy visits will be performed at Weeks 16, 20 and every eight weeks thereafter.Efficacy and safety measurements will be recorded throughout the entire 52 weeks study.Non-responders (fail to reach ASAS 40) at and after week 12 of open label therapy (at week 24), will be eligible for adalimumab dose escalation to 40 mg weekly.The study will be followed by a 24 weeks follow up phase. During this period the patients will be assessed every eight weeks.
|Charité Campus Benjamin Franklin, Rheumatology|
|Berlin, Germany, 12200|
|Herne, Germany, 44625|
|Principal Investigator:||Joachim Sieper, Prof.||Charité Campus Benjamin Franklin, Rheumatology|