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| ID | Type | Description | Link |
|---|---|---|---|
| Eudrac # 2002-000784-26 |
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The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 [DAS 28]-erythrocyte sedimentation rate [ESR] < 2.6) at Day 701 of study IM101023.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept (10 mg/Kg) | Active Comparator |
| |
| Abatacept (5 mg/Kg) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | IV solution, IV, 10 mg/Kg, Once monthly, 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse) | An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score >=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse). | Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Disease Relapse | Disease relapse is defined as additional DMARD therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 CRP score >= 3.2 at 2 consecutive visits. | After 12 Months of treatment |
| Mean Time-Matched Baseline DAS28 CRP Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25550337 | Derived | Westhovens R, Robles M, Ximenes AC, Wollenhaupt J, Durez P, Gomez-Reino J, Grassi W, Haraoui B, Shergy W, Park SH, Genant H, Peterfy C, Becker JC, Murthy B. Maintenance of remission following 2 years of standard treatment then dose reduction with abatacept in patients with early rheumatoid arthritis and poor prognosis. Ann Rheum Dis. 2015 Mar;74(3):564-8. doi: 10.1136/annrheumdis-2014-206149. Epub 2014 Dec 30. |
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Of the 433 participants who completed the main study (IM101-023 NCT00122382), 108 enrolled in the sub-study.
IM101023 (NCT00122382) was a 2-year study completing on Day 729, in which subjects were randomized to receive abatacept or placebo in combination with methotrexate (MTX) for the 1st year of the study and were then switched to open-label abatacept+MTX in the 2nd year. All subjects had received abatacept for a least 1 year prior start of sub-study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abatacept (10 mg/kg) | All subjects in the sub-study randomized to receive double-blind abatacept 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year. |
| FG001 | Abatacept (5 mg/kg) | All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abatacept (10 mg/kg) | All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg |
| BG001 | Abatacept (5 mg/kg) | All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants Experiencing Disease Relapse | Disease relapse is defined as additional DMARD therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 CRP score >= 3.2 at 2 consecutive visits. | Number of participants analyzed=number randomized. | Posted | Number | Participants | After 12 Months of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abatacept 5mg/kg (ST) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| Abatacept | Drug | IV solution, IV, 5 mg/Kg, Once monthly, 1 year |
|
|
Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). |
| Baseline |
| Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment | Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). | Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 |
| Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status) | DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). | After 12 months of treatment |
| Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment | Additional DMARD therapy is defined as a re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. | After 12 months of treatment |
| Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids | A course of high dose steroids is defined as a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). | After 12 months of treatment |
| Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment | All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg or 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. | After 12 months of treatment |
| Percentage of Participants Who Modified Therapy During Double-Blind Treatment | Modified therapy=additional DMARD therapy, 2 or more courses of high dose steroids or rescue medication. Additional DMARD therapy=re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. A course of high dose steroids=a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). Rescue medication=abatacept 10 mg/kg. | After 12 months of treatment |
| Percentage of Participants Who Lost Remission Status | Loss of remission is defined as DAS 28 CRP >=2.6. | After 12 months of treatment |
| Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment | Day 701 of the main study; sub-study Days 1, 85, 169, 253 |
| Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
| Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Infection and Infestation AEs = any AE within the System Organ Class Infection and Infestation. | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
| Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment | All neoplasms were assessed by medical review as to whether or not the event was malignant. | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
| Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Acute Infusional AE= a subset of the peri-infusional AEs with onset during the first hour after the start of the study drug infusion. A total of 105 infusional events were prespecified in the protocol. | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
| Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Peri-infusional AE=a pre-specified infusional AE occuring during the first 24 hours after the start of study drug infusion.A total of 105 infusional events were prespecified in the protocol. GDASC=General Disorders and Administration Site Conditions, RTMD=Respiratory, Thoracic and Mediastinal Disorders. | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
| Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity | A total of 127 autoimmune disorders were prespecified in the protocol. MCTD=Musculoskeletal and Connective Tissue Disorders | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
| Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment | Not evaluated: high hemoglobin,high hematocrit,high erythrocytes,high neutrophils+bands(N+B),low monocytes,low basophils,low eosinophils,low alkaline phosphatase(ALP),low aspartate aminotransferase(AST),low alanine aminotransferase(ALT),low G-Glutamyl transferase(GGT),low total bilirubin,low blood urea nitrogen,low creatinine,high albumin,low uric acid,low urine protein,low urine glucose,low urine blood,low urine leukocyte esterase,low urine white blood cells,low red blood cells.Pre Rx=pretreatment,(*)Lymphocytes(c/uL):Low<.750x10^3,High>7.50x10^3.(*)Eosinophils:>.750x10^3 c/uL. | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
| Clinically Significant Changes in Vital Signs and Physical Findings | Clinical significance was determined by investigator. Parameters include blood pressure, heart rate, respiration rate, and temperature. | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
| Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment | A positive antibody response to Abatacept (measured by the ECL assay) is further classified as a positive response for either Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig)' or 'Ig and/or Junction Region' | After 12 months of treatment |
| Lack of Efficacy |
|
| Withdrawal of Consent |
|
| Desire to Become Pregnant |
|
| Randomized by Mistake |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Weight | One participant in the 10 mg/kg group did not have weight reported. | Mean | Standard Deviation | kg |
|
| Disease Activity Scores Using C-reactive Protein (DAS 28 [CRP]) | The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).DAS 28 is a continuous variable which is a composite of 4 variables: the number of tender joints out of 28, the number of swollen joints out of 28 joints, C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm based on the following formula: DAS 28 = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Mean Time-Matched Baseline DAS28 CRP Scores | Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). | Number of participants analyzed=number of participants randomized; n=All treated participants with available DAS28 CRP scores at that time point. Mean time-matched baseline values reflect changing n-values over time. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment | Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). | Number of participants analyzed=number of participants randomized; n=the number of participants with available DAS28 CRP scores at that time point. | Posted | Mean | Standard Error | units on a scale | Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 |
|
|
|
|
| Secondary | Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status) | DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). | Number of participants analyzed= number of participants randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | After 12 months of treatment |
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|
|
| Secondary | Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment | Additional DMARD therapy is defined as a re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. | Number of participants analyzed= number of participants randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | After 12 months of treatment |
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|
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| Secondary | Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids | A course of high dose steroids is defined as a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). | Number of participants analyzed= number of participants randomized. | Posted | Number | percentage of participants | After 12 months of treatment |
|
|
|
| Primary | Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse) | An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score >=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse). | Number of participants analyzed=number of participants randomized. n=number of participants at risk at the end of a specified month. | Posted | Number | Percentage of Events | Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
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| Secondary | Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment | All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg or 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. | Number of participants analyzed= number of participants randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | After 12 months of treatment |
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|
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| Secondary | Percentage of Participants Who Modified Therapy During Double-Blind Treatment | Modified therapy=additional DMARD therapy, 2 or more courses of high dose steroids or rescue medication. Additional DMARD therapy=re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. A course of high dose steroids=a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). Rescue medication=abatacept 10 mg/kg. | Number of participants analyzed= number of participants randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | After 12 months of treatment |
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| Secondary | Percentage of Participants Who Lost Remission Status | Loss of remission is defined as DAS 28 CRP >=2.6. | Number of participants analyzed= number of participants randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | After 12 months of treatment |
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| Secondary | Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment | Number of participants analyzed= number of participants randomized; n =randomized participants with measurement at given time point. For the Day 701 measure, one apparent outlier sample was deleted.. | Posted | Mean | Standard Deviation | ng/mL | Day 701 of the main study; sub-study Days 1, 85, 169, 253 |
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| Secondary | Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | Number of participants analyzed = All treated participants during the double-blind period. | Posted | Number | percentage of participants | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
|
|
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| Secondary | Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Infection and Infestation AEs = any AE within the System Organ Class Infection and Infestation. | Number of participants analyzed = All treated participants during the double-blind period. | Posted | Number | percentage of participants | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
|
|
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| Secondary | Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment | All neoplasms were assessed by medical review as to whether or not the event was malignant. | Number of participants analyzed = All treated participants during the double-blind period. | Posted | Number | percentage of participants | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
|
|
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| Secondary | Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Acute Infusional AE= a subset of the peri-infusional AEs with onset during the first hour after the start of the study drug infusion. A total of 105 infusional events were prespecified in the protocol. | Number of participants analyzed = All treated participants during the double-blind period. | Posted | Number | percentage of participants | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
|
|
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| Secondary | Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Peri-infusional AE=a pre-specified infusional AE occuring during the first 24 hours after the start of study drug infusion.A total of 105 infusional events were prespecified in the protocol. GDASC=General Disorders and Administration Site Conditions, RTMD=Respiratory, Thoracic and Mediastinal Disorders. | Number of participants analyzed = All treated participants during the double-blind period. | Posted | Number | percentage of participants | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
|
|
|
| Secondary | Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity | A total of 127 autoimmune disorders were prespecified in the protocol. MCTD=Musculoskeletal and Connective Tissue Disorders | Number of participants analyzed = All treated participants during the double-blind period. | Posted | Number | percentage of participants | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
|
|
|
| Secondary | Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment | Not evaluated: high hemoglobin,high hematocrit,high erythrocytes,high neutrophils+bands(N+B),low monocytes,low basophils,low eosinophils,low alkaline phosphatase(ALP),low aspartate aminotransferase(AST),low alanine aminotransferase(ALT),low G-Glutamyl transferase(GGT),low total bilirubin,low blood urea nitrogen,low creatinine,high albumin,low uric acid,low urine protein,low urine glucose,low urine blood,low urine leukocyte esterase,low urine white blood cells,low red blood cells.Pre Rx=pretreatment,(*)Lymphocytes(c/uL):Low<.750x10^3,High>7.50x10^3.(*)Eosinophils:>.750x10^3 c/uL. | Number of participants analyzed = All treated participants during the double-blind period; n=number of participants with specific measure | Posted | Number | percentage of participants | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
|
|
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| Secondary | Clinically Significant Changes in Vital Signs and Physical Findings | Clinical significance was determined by investigator. Parameters include blood pressure, heart rate, respiration rate, and temperature. | This analysis was not done because clinically significant changes in vital signs and physical findings were reported as adverse events. | Posted | Number | participants | From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks) |
|
|
| Secondary | Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment | A positive antibody response to Abatacept (measured by the ECL assay) is further classified as a positive response for either Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig)' or 'Ig and/or Junction Region' | Number of participants analyzed= Number of participants with available immunogenicity measurements | Posted | Number | participants | After 12 months of treatment |
|
|
|
| 3 |
| 50 |
| 17 |
| 50 |
| EG001 | Abatacept 10mg/kg (ST) | 3 | 58 | 18 | 58 |
| EG002 | Abatacept 10mg/kg (Open-Label) | 2 | 8 | 7 | 8 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cardiopulmonary Failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Acquired Claw Toe | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Xerophtalmia | Eye disorders | MedDRA (12.0) | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hiatus Hernia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Fibrocystic Breast Disease | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| Day 85 Cohort (n=46, 42) |
|
| Day 113 Cohort (n=49, 39) |
|
| Day 141 Cohort (n=47, 40) |
|
| Day 169 Cohort (n=46, 36) |
|
| Day 197 Cohort (n=44, 38) |
|
| Day 225 Cohort (n=44, 38) |
|
| Day 253 Cohort (n=46, 37) |
|
| Day 281 Cohort (n=45, 38) |
|
| Day 309 Cohort (n=45, 37) |
|
| Day 337 Cohort (n=44, 36) |
|
| Day 365 Cohort (n=41, 35) |
|
| Day 85 (n=46, 42) |
|
| Day 113 (n=49, 39) |
|
| Day 141 (n=47, 40) |
|
| Day 169 (n=46, 36) |
|
| Day 197 (n=44, 38) |
|
| Day 225 (n=44, 38) |
|
| Day 253 (n=46, 37) |
|
| Day 281 (n=45, 38) |
|
| Day 309 (n=45, 37) |
|
| Day 337 (n=44, 36) |
|
| Day 365 (n=41, 35) |
|
Day 57 |
| ANCOVA |
Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. |
| Adjusted Difference |
| -0.09 |
| 2-Sided |
| 95 |
| -0.34 |
| 0.17 |
Change from Baseline = Post-baseline - Baseline value. |
| No |
| Superiority or Other |
| Day 85 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | -0.08 | 2-Sided | 95 | -0.37 | 0.20 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Day 113 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | -0.23 | 2-Sided | 95 | -0.50 | 0.04 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Day 141 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | 0.03 | 2-Sided | 95 | -0.26 | 0.32 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Day 169 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | -0.13 | 2-Sided | 95 | -0.41 | 0.15 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Day 197 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | -0.12 | 2-Sided | 95 | -0.38 | 0.13 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Day 225 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | -0.04 | 2-Sided | 95 | -0.32 | 0.25 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Day 253 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | 0.08 | 2-Sided | 95 | -0.19 | 0.36 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Day 281 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | 0.13 | 2-Sided | 95 | -0.12 | 0.38 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Day 309 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | -0.03 | 2-Sided | 95 | -0.27 | 0.22 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Day 337 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | -0.03 | 2-Sided | 95 | -0.37 | 0.31 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Day 365 | ANCOVA | Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate. | Adjusted Difference | 0.23 | 2-Sided | 95 | -0.09 | 0.55 | Change from Baseline = Post-baseline - Baseline value. | No | Superiority or Other |
| Month 3 (n=51, 42) |
|
| Month 4 (n=50, 38) |
|
| Month 5 (n=47, 35) |
|
| Month 6 (n=42, 33) |
|
| Month 7 (n=41, 32) |
|
| Month 8 (n=40, 31) |
|
| Month 9 (n=38, 31) |
|
| Month 10 (n=37, 31) |
|
| Month 11 (n=37, 30) |
|
| Month 12 (n=36, 28) |
|
| Sub-Study Day 85 (n=47, 43) |
|
| Sub-Study Day 169 (n=48, 43) |
|
| Sub-Study Day 253 (n=47, 42) |
|
| Related SAEs |
|
| Discontinued due to SAEs |
|
| AEs |
|
| Related AEs |
|
| Discontinued due to AEs |
|
| Nasopharyngitis |
|
| Influenza |
|
| Bronchitis |
|
| Urinary Tract Infection |
|
| Onychomycosis |
|
| Pharyngitis |
|
| Rhinitis |
|
| Ear Infection |
|
| Vaginal Infection |
|
| Appendicitis |
|
| Furuncle |
|
| Pneumonia |
|
| Sinusitis Bacterial |
|
| Endocarditis |
|
| Fungal Skin Infection |
|
| Herpes Simplex |
|
| Labyrinthitis |
|
| Oral Herpes |
|
| Respiratory Tract Infection |
|
| Sinusitis |
|
| Total Participants with AIAEs (severe) |
|
| Total Participants with AIAEs (very severe) |
|
| Vascular Disorders - Hypertension (mild) |
|
| Vascular Disorders - Hypertension (moderate) |
|
| Vascular Disorders - Hypertension (severe) |
|
| Vascular Disorders - Hypertension (very severe) |
|
| Vascular Disorders - Hypertension (unknown) |
|
| Total Participants with PIAEs (severe) |
|
| Total Participants with PIAEs (very severe) |
|
| Gastrointestinal Disorders, Nausea (mild) |
|
| Gastrointestinal Disorders, Nausea (moderate) |
|
| Gastrointestinal Disorders, Nausea (severe) |
|
| Gastrointestinal Disorders, Nausea (very severe) |
|
| Gastrointestinal Disorders, Vomiting (mild) |
|
| Gastrointestinal Disorders, Vomiting (moderate) |
|
| Gastrointestinal Disorders, Vomiting (severe) |
|
| Gastrointestinal Disorders, Vomiting (very severe) |
|
| Nervous System Disorders, Dizziness (mild) |
|
| Nervous System Disorders, Dizziness (moderate) |
|
| Nervous System Disorders, Dizziness (severe) |
|
| Nervous System Disorders, Dizziness (very severe) |
|
| Nervous System Disorders, Headache (mild) |
|
| Nervous System Disorders, Headache (moderate) |
|
| Nervous System Disorders, Headache (severe) |
|
| Nervous System Disorders, Headache (very severe) |
|
| GDASC, Malaise (mild) |
|
| GDASC, Malaise (moderate) |
|
| GDASC, Malaise (severe) |
|
| GDASC, Malaise (very severe) |
|
| GDASC, Chest Pain (mild) |
|
| GDASC, Chest Pain (moderate) |
|
| GDASC, Chest Pain (severe) |
|
| GDASC, Chest Pain (very severe) |
|
| RTMD, Asthma (mild) |
|
| RTMD, Asthma (moderate) |
|
| RTMD, Asthma (severe) |
|
| RTMD, Asthma (very severe) |
|
| RTMD, Cough (mild) |
|
| RTMD, Cough (moderate) |
|
| RTMD, Cough (severe) |
|
| RTMD, Cough (very severe) |
|
| Vascular Disorders, Hypertension (mild) |
|
| Vascular Disorders, Hypertension (moderate) |
|
| Vascular Disorders, Hypertension (severe) |
|
| Vascular Disorders, Hypertension (very severe) |
|
| Total Participants with ADs (severe) |
|
| Total Participants with ADs (very severe) |
|
| Eye Disorders - Episcleritis (mild) |
|
| Eye Disorders - Episcleritis (moderate) |
|
| Eye Disorders - Episcleritis (severe) |
|
| Eye Disorders - Episcleritis (very severe) |
|
| MCTDs - Sjogren's Syndrome (mild) |
|
| MCTDs - Sjogren's Syndrome (moderate) |
|
| MCTDs - Sjogren's Syndrome (severe) |
|
| MCTDs - Sjogren's Syndrome (very severe) |
|
| Erythrocytes, Low: <0.75 x pre rx (n=51, 48) |
|
| ALP, High: >2 x upper limit normal (ULN)(n=52, 47) |
|
| Total Calcium, Low: <0.8 x Lower LN(LLN)(n=52, 47) |
|
| Platelet Count, Low: <0.67 x LLN (n=51, 48) |
|
| Platelet Count, High: >1.5 x ULN (n=51, 48) |
|
| Leukocytes, Low: <0.75 x LLN (n=51, 48) |
|
| N+B (absolute), Low: < 1.00 x 10^3 c/uL (n=55, 49) |
|
| Lymphocytes (absolute), Low (*) (n=55, 49) |
|
| Lymphocytes (absolute), High (*) (n=55, 49) |
|
| Monocytes (absolute), High: >2000/mm^3 (n=55, 49) |
|
| Basophils (absolute), High: > 400/mm^3 (n=55, 49) |
|
| Eosinophils (absolute), High (*) (n=55, 49) |
|
| AST, High: >3 x ULN (n=52, 47) |
|
| ALT, High: >3 x ULN (n=52, 47) |
|
| GGT, High: >2 x ULN (n=52, 47) |
|
| Bilirubin Total, High: >1.5 x ULN (n=52, 46) |
|
| Blood Urea Nitrogen, High: >2 x pre rx (n=52, 47) |
|
| Serum Sodium, Low: <0.95 x LLN (n=52, 47) |
|
| Serum Sodium, High: >1.05 x ULN, (n=52, 47) |
|
| Serum Potassium, Low: <0.9 x LLN (n=52, 47) |
|
| Serum Potassium, High: >1.1 x ULN (n=52, 47) |
|
| Serum Chloride, Low: <0.9 x LLN (n=52, 47) |
|
| Serum Chloride, High: >1.1 x ULN, (n=52, 47) |
|
| Total Calcium, High: >1.2 x ULN (n=52, 47) |
|
| Inorganic Phosphorus, Low: <0.75 x LLN (n=52, 47) |
|
| Inorganic Phosphorus, High: >1.25 x ULN (n=52, 47) |
|
| Serum Glucose, Low: <65 mg/dL (n=55, 48) |
|
| Serum Glucose, High: >220 mg/dL (n=55, 48) |
|
| Total Protein, Low: <0.9 x LLN (n=52, 47) |
|
| Total Protein, High: >1.1 x ULN (n=52, 47) |
|
| Albumin, Low: <0.9 x LLN (n=52, 47) |
|
| Uric Acid, High: >1.5 x ULN (n=52, 47) |
|
| Urine Protein, High: >=2-4 (n=55, 47) |
|
| Urine Glucose, High: >=2-4 (n=55, 47) |
|
| Urine Blood, High: >=2-4 (n=55, 47) |
|
| Urine Leukocyte Esterase, High: >=2-4 (n=20, 16) |
|
| Urine White Blood Cells, High: >=2-4 (n=22, 14) |
|
| Urine Red Blood Cells, High: >=2-4 (n=22, 14) |
|