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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00537667 |
The purpose of this study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI with respect to their ability to reduce inflammation and bone and cartilage destruction in the synovium of subjects with rheumatoid arthritis.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: anakinra Drug: anakinra and PEG sTNF-R1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Single Centre, Open-Label, Randomised, Study to Evaluate the Effect of Anakinra (r-metHuIL-1ra) Alone and in Combination With PEGylated Recombinant Methionyl Human Soluble Tumour Necrosis Factor Receptor Type I (PEG sTNF-RI) on Synovial Inflammation in Subjects With Rheumatoid Arthritis. |
Enrollment: | 22 |
Study Start Date: | August 2001 |
Study Completion Date: | June 2003 |
Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
anakinra
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Drug: anakinra
anakinra
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B: Experimental
anakinra and PEGsTNF-R1
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Drug: anakinra and PEG sTNF-R1
anakinra and PEG sTNF-R1
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
And
Before any study specific procedure or screening is done, the subject or legally acceptable representative must give informed consent for participation in the study (see Section 12.2). Before buccal smears and blood samples are taken for genetic testing, the subject or legally acceptable representative must give informed consent for use of those samples for genetic testing (see Section 12.2).
Exclusion Criteria:
Felty's syndrome
Advanced or uncontrolled Diabetes Mellitus (defined as: HbA1c > 8%, peripheral neuropathy, renal/retinal involvement, or vascular disorders)
Malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, within the past five years
Any other major chronic inflammatory disease or syndrome (e.g., psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease, fibromyalgia that required treatment in the last year)
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20000211 |
Study First Received: | September 27, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00537667 History of Changes |
Health Authority: | Ireland: Irish Medicines Board |
IL-1ra PEG sTNF-RI Synovial biopsy |
Inflammation Bone and Cartilage Destruction Rheumatoid Arthritis |
Anti-Inflammatory Agents Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases TNFR-Fc fusion protein Immunosuppressive Agents Inflammation Necrosis |
Musculoskeletal Diseases Analgesics, Non-Narcotic Arthritis Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents |
Anti-Inflammatory Agents Autoimmune Diseases Immunologic Factors Immune System Diseases Joint Diseases Physiological Effects of Drugs Gastrointestinal Agents Arthritis, Rheumatoid Rheumatic Diseases TNFR-Fc fusion protein Immunosuppressive Agents Pharmacologic Actions |
Musculoskeletal Diseases Sensory System Agents Analgesics, Non-Narcotic Arthritis Therapeutic Uses Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents Central Nervous System Agents |