Arthritis, RheumatoidPhase 3NCT00663702
Phase IIIB Switching From Intravenous to Subcutaneous Study
A Phase 3 study testing Abatacept in people with Arthritis, Rheumatoid, run by Bristol-Myers Squibb at 30 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 30 sitesin 3 countries
- Study dates
- May 2008to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States18 sites
The Center For Rheumatology, Llp
Albany, New York, 12206
Walter F. Chase, Md
Austin, Texas, 78705
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, 33180
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
The Arthritis Clinic & Carolina Bone & Joint
Charlotte, North Carolina, 28210
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, 45219
Arthritis Centers Of Texas
Dallas, Texas, 75246
Unifour Medical Research
Hickory, North Carolina, 28601
Rheumatology Associates Of N. Al, P.C.
Huntsville, Alabama, 35801
Diagnostic Rheumatology And Research,Pc
Indianapolis, Indiana, 46227
Allergy & Rheumatology Medical Clinic, Inc.
La Jolla, California, 92037
Portland Rheumatology Clinic
Lake Oswego, Oregon, 97035
Innovative Health Research
Las Vegas, Nevada, 89128
Physician Research Collaboration, Llc
Lincoln, Nebraska, 68516
Valerius Medical Group &Research Ctr. Of Greater Long Beach
Long Beach, California, 90806
Desert Medical Advances
Palm Desert, California, 92260
Inland Rheumatology Clinical Trials Inc.
Upland, California, 91786
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, 19090
Canada6 sites
Local Institution
Edmonton, Alberta, T6G 2S2
Local Institution
Kitchener, Ontario, N2M 5N6
Local Institution
Montreal, Quebec, H2L 1S6
Local Institution
Québec, Quebec, G1V 3M7
Local Institution
St. John's, Newfoundland and Labrador, A1A 5E8
Local Institution
Toronto, Ontario, M5G 1X5
Mexico6 sites
Local Institution
Guadalajara, Jalisco, 44690
Local Institution
Mexico City, Mexico City, 06726
Local Institution
Mexico City, Mexico City, 14080
Local Institution
Nuevo León, Nuevo León, 64020
Local Institution
San Luis Potosí City, San Luis Potosí, 78240
Local Institution
Tijuana, Estado de Baja California, 22320
About this 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
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
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Abatacept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called Orencia, BMS-188667
Subcutaneous injection, 125 mg/mL, once weekly, 48 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.
Measured: Day 1 (Baseline) through Day 85
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
An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.
Measured: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) >3 decrease from preRx. Hematocrit (%)<0.75*preRx. Erythrocytes (*10^6 c/uL) <0.75*preRx. Platelet count (*10^9 c/L) <0.67*LLN or 1.5*ULN or, if preRx<LLN, use <0.5*preRx and <100,000 mm^3. Leukocytes (*10^3 c/uL) <0.75*LLN or >1.25*ULN or, if preRx<LLN, use <0.8*preRx or >ULN or, if preRx>ULN, use >1.2*preRx or <LLN. Eosinophils >0.750*10^3 c/uL. Lymphocytes <0.750*10^3 c/uL or >7.50*10^3 c/uL.
Measured: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) >2*ULN or if preRx>ULN, use 3*preRx. Alanine aminotransferase (U/L)>3*ULN or if preRx>ULN, use >4*preRx. G-glutamyl transferase (U/L)>2*ULN or if preRx>ULN, use >3*preRx. Blood urea nitrogen (mg/dL)>2*preRx. Creatinine (mg/dL)>1.5*preRx.
Measured: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: <0.95*LLN or >1.05*ULN or if preRx<LLN, <0.95*preRx or >ULN, or if preRx>ULN,>1.05*preRx or <LLN. Potassium,serum: <0.9*LLN or >1.1*ULN or if preRx<LLN, use <0.9*preRx or >ULN or if preRx>ULN, 1.1*preRx or <LLN. Phosphorus: 0.75*LLN or 1.25*ULN or, if preRx<LLN, <0.67*preRx or >ULN or, if preRx>ULN, <LLN.
Measured: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .
Measured: Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period
Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality
preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use >=2 or, if value >= 4, or if preRx=0 or 0.5, use >=2 or, if preRx= 1, use >=3 or, if preRx=2 or 3, use >=4.
Measured: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
Number of Participants With Adverse Events of Special Interest
AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).
Measured: Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Measured: 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
Mean Heart Rate
Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Measured: 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
Mean Temperature
Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Measured: 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 (6)
Mean Trough Serum Concentration (Cmin) of Abatacept
Cmin of abatacept was determined from serum samples.
Measured: Days 29, 85, 57, and 85
Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85
Using the ELISA, any positive (titer of 400 or greater) postbaseline sample was classified as positive immunogenicity. The percentage of participants with at least 1 positive antibody response (anti-abatacept and/or anti-CTLA4-T) during the 85 days was tabulated by antibody specificity and overall.
Measured: Day 1 (Baseline) through Day 85
Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85
Number of participants was tabulated using ECL assay with at least 1 positive abatacept-induced immunogenic response (CTLA4 and possibly Ig, Ig and/or Junction Region) in the first 85 days. Positive response (titers >10) included:
- A missing baseline immunogenicity measurement and a positive immunogenicity response postbaseline
- A negative baseline immunogenicity response and a positive immunogenicity response postbaseline
- A positive baseline immunogenicity response and a positive immunogenicity response postbaseline that has a titer value strictly greater than the baseline titer value
Measured: Day 1 (Baseline) through Day 85
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Measured: Day 1 (Baseline) through Day 1093
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:
LDAS is defined as DAS 28-CRP ≤3.2. DAS 28-CRP remission is defined as DAS 28-CRP <2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Measured: Day 1 (Baseline) through Day 1093
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
The HAQ-DI assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories is divided by the number of categories answered, yielding a score from 0-3.
Measured: Day 1 (Baseline) to Day 1093
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663702
- Sponsor's protocol ID
- IM101-185
- Status last verified
- Feb 2015
- First submitted
- 18 Apr 2008
- Last updated
- 9 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27229685
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00663702
- Acronym / sponsor ID
- IM101-185
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 26 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Abatacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptAlso: Orencia, BMS-188667Subcutaneous injection, 125 mg/mL, once weekly, 48 months | Drug | 1 |
Primary outcome
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
Time frame: Day 1 (Baseline) through Day 85
An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.
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
Time frame: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Time frame: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) >3 decrease from preRx. Hematocrit (%)<0.75*preRx. Erythrocytes (*10^6 c/uL) <0.75*preRx. Platelet count (*10^9 c/L) <0.67*LLN or 1.5*ULN or, if preRx<LLN, use <0.5*preRx and <100,000 mm^3. Leukocytes (*10^3 c/uL) <0.75*LLN or >1.25*ULN or, if preRx<LLN, use <0.8*preRx or >ULN or, if preRx>ULN, use >1.2*preRx or <LLN. Eosinophils >0.750*10^3 c/uL. Lymphocytes <0.750*10^3 c/uL or >7.50*10^3 c/uL.
Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Time frame: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) >2*ULN or if preRx>ULN, use 3*preRx. Alanine aminotransferase (U/L)>3*ULN or if preRx>ULN, use >4*preRx. G-glutamyl transferase (U/L)>2*ULN or if preRx>ULN, use >3*preRx. Blood urea nitrogen (mg/dL)>2*preRx. Creatinine (mg/dL)>1.5*preRx.
Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Time frame: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: <0.95*LLN or >1.05*ULN or if preRx<LLN, <0.95*preRx or >ULN, or if preRx>ULN,>1.05*preRx or <LLN. Potassium,serum: <0.9*LLN or >1.1*ULN or if preRx<LLN, use <0.9*preRx or >ULN or if preRx>ULN, 1.1*preRx or <LLN. Phosphorus: 0.75*LLN or 1.25*ULN or, if preRx<LLN, <0.67*preRx or >ULN or, if preRx>ULN, <LLN.
Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
Time frame: Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .
Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality
Time frame: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period
preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use >=2 or, if value >= 4, or if preRx=0 or 0.5, use >=2 or, if preRx= 1, use >=3 or, if preRx=2 or 3, use >=4.
Number of Participants With Adverse Events of Special Interest
Time frame: Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period
AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Time frame: 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
BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Mean Heart Rate
Time frame: 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
Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Mean Temperature
Time frame: 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
Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
6 secondary outcomes
Mean Trough Serum Concentration (Cmin) of Abatacept
Time frame: Days 29, 85, 57, and 85
Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85
Time frame: Day 1 (Baseline) through Day 85
Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85
Time frame: Day 1 (Baseline) through Day 85
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Time frame: Day 1 (Baseline) through Day 1093
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:
Time frame: Day 1 (Baseline) through Day 1093
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Time frame: Day 1 (Baseline) to Day 1093
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27229685Alten 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abatacept in people with Arthritis, Rheumatoid, run by Bristol-Myers Squibb at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Day 1 (Baseline) through Day 85). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00663702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.