|ClinicalTrials.gov Identifier: NCT00235105|
Recruitment Status : Unknown
Verified October 2005 by Charite University, Berlin, Germany.
Recruitment status was: Active, not recruiting
First Posted : October 10, 2005
Last Update Posted : December 9, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Ankylosing Spondylitis||Drug: Adalimumab 40 mg sc every other week||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Adalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension Phase|
|Study Start Date :||March 2005|
|Estimated Study Completion Date :||June 2007|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235105
|Charité Campus Benjamin Franklin, Rheumatology|
|Berlin, Germany, 12200|
|Herne, Germany, 44625|
|Principal Investigator:||Joachim Sieper, Prof.||Charité Campus Benjamin Franklin, Rheumatology|