A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00767325
First received: October 6, 2008
Last updated: December 8, 2011
Last verified: December 2011
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Purpose
The purpose of the study is to assess early signs of response to Abatacept+MTX my measuring improvement of your hand joints inflammation by using an ultrasound machine.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Abatacept |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Abatacept
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Power Doppler Ultrasonography (PDUS) assessments of the MCP joints (2-5th) of both hands [ Time Frame: at screening and all visits until 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Global PDUS score, total PDUS score and components, and DAS28-CRP or DAS29-CRP derived criteria [ Time Frame: at specified timepoints during the study ] [ Designated as safety issue: No ]
| Enrollment: | 104 |
| Study Start Date: | December 2008 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Abatacept
Abatacept solution, IV, <60 kg will receive 500 mg, 60-100 kg will receive 750 mg, >100 kg will receive 100 mg on Day 1, Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, and Day 169
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Disease activity defined by a DAS28-CRP > 3.2, or all of the following criteria must be met; a tender joint count of ≥6, and a C-reactive protein (CRP) measurement greater than the upper limit of normal (ULN)
- Diagnosis of RA for more than 6 months
- Total synovitis PDUS score >1 for at least 2 MCP joints (MCP2-5) and a total synovitis PDUS score ≥ 1 for at least one other MCP (MCP2-5)
- Concomitant treatment with methotrexate for at least 3 months
- No treatment with any background non biologic DMARD other than methotrexate for at least 28 days before treatment (Day 1)
- Naive to treatment with biologic DMARDs
Exclusion Criteria:
- Women of childbearing potential who are unwilling or unable to use birth control, specific medical history and concurrent diseases
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767325
Locations
| Denmark | |
| Local Institution | |
| Glostrup, Denmark, DK-2600 | |
| France | |
| Local Institution | |
| Bois Guillaume Cedex, France, 76230 | |
| Local Institution | |
| Boulogne, France, 92104 | |
| Local Institution | |
| Echirolles, France, 38434 | |
| Local Institution | |
| Nice Cedex 03, France, 06202 | |
| Germany | |
| Local Institution | |
| Munchen, Germany, 80639 | |
| Hungary | |
| Local Institution | |
| Budapest, Hungary, 1036 | |
| Italy | |
| Local Institution | |
| Jesi (Ancona), Italy, 60035 | |
| Local Institution | |
| Pisa, Italy, 56126 | |
| Local Institution | |
| Roma, Italy, 00161 | |
| Local Institution | |
| Roma, Italy, 00168 | |
| Local Institution | |
| Siena, Italy, 53100 | |
| Local Institution | |
| Verona, Italy, 37126 | |
| Norway | |
| Local Institution | |
| Oslo, Norway, N0319 | |
| Local Institution | |
| Trondheim, Norway, 7006 | |
| Spain | |
| Local Institution | |
| Barcelona, Spain, 08006 | |
| Local Institution | |
| Madrid, Spain, 28040 | |
| Local Institution | |
| Madrid, Spain, 28006 | |
| Local Institution | |
| Madrid, Spain, 28935 | |
| Local Institution | |
| Madrid, Spain, 28911 | |
| United Kingdom | |
| Local Institution | |
| Leeds, North Yorkshire, United Kingdom, LS7 4SA | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00767325 History of Changes |
| Other Study ID Numbers: | IM101-179 |
| Study First Received: | October 6, 2008 |
| Last Updated: | December 8, 2011 |
| Health Authority: | France: Ministry of Health Spain: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency Italy: Ministry of Health Norway: Norwegian Medicines Agency Denmark: Ethics Committee Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Abatacept Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013