Phase IIIB Subcutaneous Missed Dose Study
A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis
1 other identifier
interventional
270
5 countries
27
Brief Summary
The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Nov 2007
Longer than P75 for phase_3 rheumatoid-arthritis
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 24, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedResults Posted
Study results publicly available
June 3, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedApril 23, 2015
April 1, 2015
1.1 years
September 20, 2007
January 10, 2011
April 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169
Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using an enzyme-linked immunosorbent assay (ELISA). Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Day 169
Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups
Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Day 253 (short term)
Secondary Outcomes (65)
RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group
Day 253 (short term)
Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug
LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time
For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug
DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time
Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period
DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Post Visits
Day 22 after last dose of drug to Day 85 after last dose of drug
- +60 more secondary outcomes
Study Arms (2)
Abatacept
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Rheumatoid Arthritis
- Disease Activity Score (DAS)28-C-Reactive Protein (CRP) score ≥ 3.2 and ≤5.1
- On background methotrexate at least 3 months (≥10mg weekly)
- Must be able to self injection or allow a care giver to do it for them
- Discontinue all Biologics and Disease-Modifying Anti-rheumatic Drugs (DMARDs) except for methotrexate
You may not qualify if:
- Participants who had prior exposure to abatacept or CTLA-4 Ig
- Received treatment with rituximab.
- Participants who have received treatment with leflunomide within 1 year of screening
- Participants who have received treatment with immunoadsorption columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Wallace Rheumatic Study Center
Los Angeles, California, 90048, United States
New England Research Associates, Llc
Trumbull, Connecticut, 06611, United States
Sarasota Arthritis Research Center
Sarasota, Florida, 34239, United States
Diagnostic Rheumatology And Research,Pc
Indianapolis, Indiana, 46227, United States
Klein And Associates, M.D., Pa
Cumberland, Maryland, 21502, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
St. Paul Rheumatology, P.A.
Eagan, Minnesota, 55121, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, 18015, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Center For Assessment And Research Of Erie
Erie, Pennsylvania, 16508, United States
Columbia Arthritis Center
Columbia, South Carolina, 29204, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, United States
Local Institution
Capital Federal, Buenos Aires, 1015, Argentina
Local Institution
Córdoba, Córdoba Province, 5000, Argentina
Local Institution
Rosario, Santa Fe Province, 2000, Argentina
Local Institution
Santa Fe, Santa Fe Province, 3000, Argentina
Local Institution
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Local Institution
León, Guanajuato, 37520, Mexico
Local Institution
Mexico City, Mexico City, 06726, Mexico
Local Institution
Metepec, State of Mexico, 52140, Mexico
Local Institution
Mérida, Yucatán, 97000, Mexico
Local Institution
Bloemfontein, Free State, 9317, South Africa
Local Institution
Muckleneuk, Gauteng, 0002, South Africa
Local Institution
Pretoria, Gauteng, 0084, South Africa
Local Institution
Berea, KwaZulu-Natal, 4001, South Africa
Local Institution
Panorama, Western Cape, 7500, South Africa
Related Publications (1)
Kaine J, Gladstein G, Strusberg I, Robles M, Louw I, Gujrathi S, Pappu R, Delaet I, Pans M, Ludivico C. Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase Iiib ALLOW study). Ann Rheum Dis. 2012 Jan;71(1):38-44. doi: 10.1136/annrheumdis-2011-200344. Epub 2011 Sep 13.
PMID: 21917824DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BMS Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 24, 2007
Study Start
November 1, 2007
Primary Completion
December 1, 2008
Study Completion
February 1, 2014
Last Updated
April 23, 2015
Results First Posted
June 3, 2011
Record last verified: 2015-04