Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After SC Administration to Subjects With RA - Tabular View

Tracking Information

First Received Date ^ICMJE

November 15, 2005

Last Updated Date

September 2, 2009

Start Date ^ICMJE

January 2006

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assess the steady-state trough serum concentration of abatacept following weekly SC dosing in subjects with active RA [ Time Frame: before and at the end of the IV dose, just prior to each SC dose, and on 4 days between doses ] [ Designated as safety issue: Yes ]
The primary objective of the open-label period is to assess the safety, immunogenicity and long term tolerability of subcutaneous administration of abatacept in subjects who have completed the initial 12-week treatment with abatacept [ Time Frame: safety monitoring every 4 weeks; immunogenicity every 12 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

This study will measure the pharmacokinetics of abatacept administered subcutaneously. PK samples are collected before and at the end of the IV dose, just prior to each SC dose, and on 4 days between doses

Change History

Complete list of historical versions of study NCT00254293 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the safety and tolerability of abatacept administered SC in RA subjects [ Time Frame: are collected every 2 weeks and at follow-up visits - short term ] [ Designated as safety issue: Yes ]
To assess the immunogenicity of abatacept administered SC in RA subjects [ Time Frame: are collected every 2 weeks and at follow-up visits - short term ] [ Designated as safety issue: Yes ]
To examine the effect of SC administered abatacept on serum levels of RF in RA subjects [ Time Frame: on regular intervals and at Study Discharge - short term ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Samples for anti-CTLA4Ig and anti-CTLA4 are collected every 2 weeks and at follow-up visits. Rheumatoid Factor is colleted on regular intervals and at Study Discharge.

Descriptive Information

Brief Title ^ICMJE

Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After SC Administration to Subjects With RA

Official Title ^ICMJE

A Study to Assess the Steady-State Trough Serum Concentration, Safety, and Immunogenicity of Abatacept (BMS-188667) Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Who Are Receiving Disease Modifying Ant-Rheumatic Drugs (DMARDs)

Brief Summary

The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: Abatacept or Placebo (both as IV & SC Solution)
Drug: Abatacept or Placebo (both as IV & SC solution)
Drug: Abatacept

Study Arms / Comparison Groups

Experimental: Long Term

Publications *

Westhovens R, Kremer JM, Moreland LW, Emery P, Russell AS, Li T, Aranda R, Becker JC, Qi K, Dougados M. Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB study. J Rheumatol. 2009 Apr;36(4):736-42. Epub 2009 Feb 27.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

January 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Meet ARA criteria for diagnosis of RA with acitive disease.
RA diagnosis for at least 1 year.
> = 6 swollen joints.
> = 8 tender joints.
Taking MTX or MTX plus not more thatn 1 added oral DMARD for > = 3 months and stable for 28 days prior to dosing.

Exclusion Criteria:

Serious acute or bacterial infection in last 3 months.
Chronic or recurrent bacterial infections.
History of TB within previous 3 years or old TB not adequately treated.
Specific lab test abnormalities
History of cancer within 5 years.
Exposure to CTLA4lg, bleatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic.
Treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenylate mofetil, cyclosporine, D-Penicillamine or calcineurin inhibitors.
Exposure to live vaccines.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00254293

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

IM101-063

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP