Phase IIIB Switching From Intravenous to Subcutaneous Study - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00663702

Purpose

The purpose of this study is to determine whether switching to subcutaneous administration of abatacept will be safe in RA subjects who previously received long-term therapy with intravenous (IV) abatacept

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: Abatacept	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	A Phase 3B Multi-Center Open-Label Study to Evaluate the Safety of Abatacept in Subjects Who Switch From Intravenous to Subcutaneous Abatacept Therapy

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

There is no primary efficacy endpoint as the primary objective is to describe the safety for subjects switching from IV to SC abatacept [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

There is no secondary efficacy endpoint as the secondary objective is to describe the trough serum concentrations and immunogenicity [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	136
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Abatacept IV Solution, Subcutaneous, 125 mg, once weekly, 48 months

Eligibility

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

Criteria

Subjects will only be recruited from two BMS studies (IM101-029 and IM101-102)

Inclusion Criteria:

Subjects must have completed their final quarterly dosing visit in IM101-029 or IM101-102 studies as follows:
- US and Canadian subjects = Day 1821 visit
- Taiwanese subjects = Day 1905 visit
- Mexican subjects = Day 1989 visit
Subjects must have consented to the IM101-185 study on their final quarterly dosing visit in IM101-029 or IM101-102 studies as follows:
- US and Canadian subjects = Day 1821 visit
- Taiwanese subjects = Day 1905 visit
- Mexican subjects = Day 1989 visit
At the time of completion in the IM101-029 or IM101-102 protocol, subjects did not meet any of the criteria that would have required them to discontinue the study.
Drug stabilization requirements: Subjects who receive concomitant medications (DMARDs, corticosteroids, and non-steroidal anti-inflammatory drugs (NSAIDs)) at the time of their last quarterly dosing visit for IM101-029 or IM101-102 are required to maintain stable dose levels from the time they sign consent until the end of the first three months (Day 85) of this study.

Exclusion Criteria:

The following treatment or therapies should not be started on or after the final quarterly dosing visit from the IM101-029 or IM101-102 studies:
- Any biologic
- Immunoabsorption columns (such as Prosorba columns)
- IMycophenolate mofetil (Cellcept)
- Cyclosporin A or other calcineurin inhibitors
- D-Penicillamine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663702

Show 31 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:	IM101-185
Study First Received:	April 18, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00663702 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Mexico: National Institute of Public Health, Health Secretariat

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