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Sponsors and Collaborators: |
Charite University, Berlin, Germany Bristol-Myers Squibb |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00558506 |
This is an open-label trial investigating the efficacy and safety of abatacept in ankylosing spondylitis. It is planned to treat 30 patients with ankylosing spondylitis from baseline up to week 30. Abatacept will be administered intravenously according to the prescription used in rheumatoid arthritis.
Condition | Intervention | Phase |
---|---|---|
Ankylosing Spondylitis |
Drug: abatacept |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis |
Estimated Enrollment: | 30 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Abatacept
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Drug: abatacept
intravenously 750mg (in patients with weight of 60- 100kg)
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients 18 - 65 years of age who have moderate to severe ankylosing spondylitis.
Group
Exclusion Criteria:
Main Inclusion/Exclusion Criteria
Exclusion criteria related to general health conditions
Exclusion criteria related to medications
Exclusion criteria related to lab findings
Exclusion criteria related to formal aspects
Contact: Joachim Sieper, MD | +49-(0)30-8445- ext 4535 | joachim.sieper@charite.de |
Contact: In-Ho Song, MD | +49-(0)30-8445- ext 4795 | in-ho.song@charite.de |
Germany | |
Charité University Medicine Berlin, Campus Benjamin-Franklin | Recruiting |
Berlin, Germany, 12200 | |
Contact: Joachim Sieper, MD +49-(0)30-8445- ext 4547 joachim.sieper@charite.de | |
Contact: In-Ho Song, MD +49-(0)30-8445- ext 4795 in-ho.song@charite.de | |
Principal Investigator: Joachim Sieper, MD | |
Sub-Investigator: Anna Amtenbrink, MD | |
Sub-Investigator: In-Ho Song, MD | |
Rheumazentrum Ruhrgebiet | Recruiting |
Herne, Germany, 44652 | |
Contact: Jürgen Braun, MD +49-(0)2325-592 ext 138 j.braun@rheumazentrum-ruhrgebiet.de | |
Contact: Frank Heldmann, MD +49-(0)2325-592 ext 709 heldmann@rheumazentrum-ruhrgebiet.de | |
Principal Investigator: Jürgen Braun, MD | |
Sub-Investigator: Frank Heldmann, MD | |
Sub-Investigator: Ertan Saracbasi-Zender, MD |
Principal Investigator: | Joachim Sieper, MD | Charité University Medicine Berlin, Campus Benjamin Franklin, Medical Department I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany |
Study ID Numbers: | ABATACEPT-AS-01 |
Study First Received: | November 14, 2007 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00558506 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Ankylosing spondylitis activity treatment clinical trial |
Spinal Diseases Abatacept Musculoskeletal Diseases Spondylarthropathy Arthritis Joint Diseases |
Spondylitis, Ankylosing Spondylarthritis Bone Diseases Spondylitis Ankylosis Spondylarthropathies |
Immunologic Factors Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents |
Infection Immunosuppressive Agents Pharmacologic Actions Bone Diseases, Infectious |