Clinical trial NCT00663702: Phase IIIB Switching From Intravenous to Subcutaneous 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether switching to subcutaneous administration of abatacept will be safe in participants with rheumatoid arthritis who previously received long-term therapy with intravenous abatacept


Eligibility criteria: Inclusion Criteria:

* Recruitment from 2 Bristol-Myers Squibb (BMS) studies (BMS IM101-029 \[NCT00048581\] and BMS IM101-102 \[NCT00048568\]).
* Completion of final quarterly dosing visit in NCT00048581 or NCT00048568 as follows: US and Canadian participants: Day 1821 visit; Taiwanese participants: Day 1905 visit; Mexican participants: Day 1989 visit.
* Agreement to participate in BMS IM101-185 (NCT00663702) on final quarterly dosing visit in NCT00048581 or NCT00048568 study as follows: US and Canadian participants: Day 1821 visit; Taiwanese participants: Day 1905 visit; Mexican participants: Day 1989 visit.
* At the time of completion of the NCT00048581 or NCT00048568 protocol, participant did not meet any criteria requiring their discontinuation.
* Drug stabilization requirements: Participants who received concomitant medications (disease-modifying antirheumatic drugs, corticosteroids, and nonsteroidal anti-inflammatory drugs) at the time of their last quarterly dosing visit for NCT00048581 or NCT00048568 were required to maintain stable dose levels from the time they signed consent until the end of the first 3 months (Day 85) of the current study.
* Willingness to self-inject study medication (abatacept) or allow a caregiver to inject study medication.
* Willingness to adhere to study visit schedule and comply with other protocol requirements.
* Male or female (not nursing or pregnant)genders, at least 18 years of age. Women of childbearing potential (WOCBP) must have been practicing adequate contraceptive measures during the study and for up to 10 weeks after the last infusion of study medication in such a manner that the risk of pregnancy was minimized. WOCBP must have had a negative serum or urine pregnancy test result (minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 48 hours prior to the start of study medication.

Exclusion Criteria:

* The following treatment or therapies should not be started on or after the final quarterly dosing visit from the NCT00048581 or NCT00048568 study: Any biologic; immunoabsorption columns (such as Prosorba columns); mycophenolate mofetil; cyclosporin A or other calcineurin inhibitors; D-penicillamine; any live vaccines within 3 months of Day 1 or scheduled to receive a live vaccine during the course of the study
* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, or a concomitant medical condition that, in the opinion of the Investigator, might have placed the participation at unacceptable risk for study participation
* Any clinical laboratory test result that was considered to be abnormal or not within acceptable limits on the final quarterly dosing visit of NCT00048581 or NCT00048568. Screening laboratory test results for NCT00663702 were based on the Day 1821 visit of NCT00048581 or NCT00048568 for participants enrolled at sites in the US or Canada and on the Day 1989 visit of NCT00048568 for participants enrolled at sites in Mexico.
* Imprisonment or involuntarily incarceration for treatment of either a psychiatric or physical (eg, infectious disease) illness
* Impairment, incapacitation, inability to complete study-related assessments, or illiteracy.

Primary outcomes:
measure: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
timeFrame: Day 1 (Baseline) through Day 85
measure: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
timeFrame: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
measure: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
timeFrame: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
measure: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
timeFrame: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
measure: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
timeFrame: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
measure: Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
timeFrame: Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period
measure: Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality
timeFrame: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
measure: Number of Participants With Adverse Events of Special Interest
timeFrame: Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period
measure: Mean Sitting Systolic and Diastolic Blood Pressure (BP)
timeFrame: Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821
measure: Mean Heart Rate
timeFrame: Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821
measure: Mean Temperature
timeFrame: Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821
Secondary outcomes:
measure: Mean Trough Serum Concentration (Cmin) of Abatacept
timeFrame: Days 29, 85, 57, and 85
measure: Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85
timeFrame: Day 1 (Baseline) through Day 85
measure: Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85
timeFrame: Day 1 (Baseline) through Day 85
measure: Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
timeFrame: Day 1 (Baseline) through Day 1093
measure: Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
timeFrame: Day 1 (Baseline) through Day 1093
measure: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
timeFrame: Day 1 (Baseline) to Day 1093
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates Of N. Al, P.C.
state: Alabama
city: La Jolla
country: United States
facility: Allergy & Rheumatology Medical Clinic, Inc.
state: California
city: Long Beach
country: United States
facility: Valerius Medical Group &Research Ctr. Of Greater Long Beach
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials Inc.
state: California
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties
state: Florida
city: Indianapolis
country: United States
facility: Diagnostic Rheumatology And Research,Pc
state: Indiana
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Lincoln
country: United States
facility: Physician Research Collaboration, Llc
state: Nebraska
city: Las Vegas
country: United States
facility: Innovative Health Research
state: Nevada
city: Albany
country: United States
facility: The Center For Rheumatology, Llp
state: New York
city: Charlotte
country: United States
facility: The Arthritis Clinic & Carolina Bone & Joint
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group
state: Ohio
city: Lake Oswego
country: United States
facility: Portland Rheumatology Clinic
state: Oregon
city: Willow Grove
country: United States
facility: Rheumatic Disease Associates, Ltd.
state: Pennsylvania
city: Austin
country: United States
facility: Walter F. Chase, Md
state: Texas
city: Dallas
country: United States
facility: Arthritis Centers Of Texas
state: Texas
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: St. John'S
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Kitchener
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
city: Tijuana
country: Mexico
facility: Local Institution
state: Baja California
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Nuevo Leon
country: Mexico
facility: Local Institution
city: San Luis Potosi
country: Mexico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.