Phase IIIB Subcutaneous Missed Dose Study - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00533897

Purpose

The purpose of the study is to determine if subcutaneous abatacept administered to patients with rheumatoid arthritis (RA) is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Abatacept Drug: Placebo	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Official Title:	A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Safety, Immunogenicity, and Efficacy of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Immunogenicity and safety [ Time Frame: Day 1, 57, 78, 85, 113, 141, 169, 197, 225, ET and every 12 weeks in long term. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

DAS28-CRP [ Time Frame: Monthly for short term, Quarterly for long term ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Abatacept: Experimental	Drug: Abatacept Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly, Period II, 12 weeks (Short Term has 3 periods)
Placebo: Placebo Comparator	Drug: Placebo Solution in pre-filled syringes, Subcutaneously, 0 mg, Weekly, Period II 12 weeks (Short Term has 3 periods)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of Rheumatoid Arthritis
DAS28-CRP score ≥ 3.2 and ≤ 5.1
On background methotrexate only
Must be able to self injection or allow a care giver to do it for them
Discontinue all Biologics and DMARDS except for methotrexate

Exclusion Criteria:

Received treatment with rituximab.
Subjects who have received treatment with leflunomide, immunoadsorbtion columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533897

Show 27 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-167
Study First Received:	September 20, 2007
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00533897 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Rheumatoid Arthritis (RA)

Study placed in the following topic categories:

Abatacept
Autoimmune Diseases
Immunologic Factors
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antirheumatic Agents
Immunosuppressive Agents

Additional relevant MeSH terms:

Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid
Rheumatic Diseases
Immunosuppressive Agents

Pharmacologic Actions
Abatacept
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009