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The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071, IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX intolerance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Participants from Phase I study (IM101-034) | Experimental |
| |
| Arm 2: Participants from Phase II study (IM101-071) | Experimental |
| |
| Arm 3: New Participants with Methotrexate (MTX) Intolerance | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants > 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included. | From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). |
| Number of Participants With Abnormal Laboratory Changes (ALC) | The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations. | From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). |
| Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Nagoya | Aichi-ken | 460-0001 | Japan | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24754273 | Derived | Takeuchi T, Matsubara T, Urata Y, Suematsu E, Ohta S, Honjo S, Abe T, Yamamoto A, Miyasaka N; Japan Abatacept Study Group. Phase III, multicenter, open-label, long-term study of the safety of abatacept in Japanese patients with rheumatoid arthritis and an inadequate response to conventional or biologic disease-modifying antirheumatic drugs. Mod Rheumatol. 2014 Sep;24(5):744-53. doi: 10.3109/14397595.2014.899179. Epub 2014 Apr 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Long Term Phase |
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| At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. |
| Percentage of Participants With ACR 50 Response Over Time | ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. |
| Percentage of Participants With ACR 70 Response Over Time | ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. |
| Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of > 5.1), low disease activity (change of ≤ 3.2) and remission (< 2.6). Please see outcome 8 for change from BL data. | At BL (week 0), week 24, 48, 96, 144, and 192. |
| Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Please refer to outcome 7 for BL and PBL values. | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
| Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement. | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
| Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity. | At weeks 24, 48, 96, 144, and 192. |
| Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score < 2.6 were considered to be in remission. | At weeks 24, 48, 96, 144, and 192. |
| Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from BL in HAQ. | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
| Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data. | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
| Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values. | At baseline (week 0), weeks 24, 48, 96, 144, and 192. |
| Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data. | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
| Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values. | At BL (Week 0), weeks 24, 48, 96, 144, and 192. |
| Baseline and Postbaseline C-reactive Protein (CRP) Levels | CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data. | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
| Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value * 100. Please refer to outcome 17 for BL and PBL values. | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
| Baseline and Postbaseline Rheumatoid Factor Levels | Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please see outcome 20 for change from BL data. | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
| Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please refer to outcome 19 for BL and PBL values. | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
| Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies | Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. | At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192. |
| Abatacept PK Parameter: Total Body Clearance | Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism. | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
| Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State | Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule. | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
| Abatacept PK Parameter: Maximum Serum Concentration at Steady State | Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max). | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
| Abatacept PK Parameter: Minimum Plasma Concentration at Steady State | Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state. | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
| Nagoya |
| Aichi-ken |
| 466-8550 |
| Japan |
| Local Institution | Goshogawara-Shi | Aomori | 037-0053 | Japan |
| Local Institution | Chiba | Chiba | Japan |
| Local Institution | Fukui-shi | Fukui | 910-0041 | Japan |
| Local Institution | Fukui-shi | Fukui | 9100067 | Japan |
| Local Institution | Fukui-shi | Fukui | 9103133 | Japan |
| Local Institution | Fukuoka | Fukuoka | 810-0065 | Japan |
| Local Institution | Fukuoka | Fukuoka | 812-0025 | Japan |
| Local Institution | Kitakyushu-Shi | Fukuoka | 807-8555 | Japan |
| Local Institution | Higashi-Hiroshima-Shi | Hiroshima | 739-0002 | Japan |
| Local Institution | Sapporo | Hokkaido | 060-0001 | Japan |
| Local Institution | Sapporo | Hokkaido | 060-8604 | Japan |
| Local Institution | Sapporo | Hokkaido | 060-8648 | Japan |
| Local Institution | Kanzaki-Gun | Hyōgo | 679-2414 | Japan |
| Local Institution | Kato-Gun | Hyōgo | 673-1462 | Japan |
| Local Institution | Hitachi-Shi | Ibaraki | 316-0035 | Japan |
| Local Institution | Tsukuba | Ibaraki | 305-0005 | Japan |
| Local Institution | Sagamihara-Shi | Kanagawa | 228-8522 | Japan |
| Local Institution | Sendai | Miyagi | 981-0911 | Japan |
| Local Institution | Sendai | Miyagi | 982-0032 | Japan |
| Local Institution | Sendai | Miyagi | Japan |
| Local Institution | Nagano | Nagano | 380-8582 | Japan |
| Local Institution | Tsukubo-Gun | Okayama-ken | 701-0304 | Japan |
| Local Institution | Kawachinagano-Shi | Osaka | 86-0008 | Japan |
| Local Institution | Ureshino-Shi | Saga-ken | 843-0301 | Japan |
| Local Institution | Iruma-Gun | Saitama | 350-0495 | Japan |
| Local Institution | Kawagoe-Shi | Saitama | 350-8550 | Japan |
| Local Institution | Kitamoto-Shi | Saitama | 364-0026 | Japan |
| Local Institution | Hamamatsu | Shizuoka | 430-0906 | Japan |
| Local Institution | Kawachigun | Tochigi | 329-1104 | Japan |
| Local Institution | Shimotsuke-Shi | Tochigi | 3290498 | Japan |
| Local Institution | Arakawa-Ku | Tokyo | 116-0011 | Japan |
| Local Institution | Bunkyo-Ku | Tokyo | 113-0022 | Japan |
| Local Institution | Bunkyo-Ku | Tokyo | 113-8519 | Japan |
| Local Institution | Setagaya-Ku | Tokyo | 155-0032 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 162-0054 | Japan |
| Local Institution | Takaoka-Shi | Toyama | 933-8525 | Japan |
| Local Institution | Chiba | 260-0801 | Japan |
| FG001 |
| Participants From Phase II Study(IM101-071); Abatacept 10mg/kg |
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| FG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| COMPLETED |
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| NOT COMPLETED |
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| Post Marketing Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. |
| BG001 | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| BG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| Duration of Rheumatoid Arthritis | Number | participants |
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| American College of Rheumatology (ACR) Functional Status Classification | ACR Classification Criteria for Determining Progression of Rheumatoid Arthritis - Class I: Completely able to perform usual activities of daily living; II: Able to perform usual self-care and vocational activities, but limited in avocational activities ; III: Able to perform usual self-care activities, but limited in vocational and avocational activities ; IV: Limited ability to perform usual self-care, vocational, and avocational activities | Number | participants |
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| Number of Tender Joints | Tender joints are an indicator of Rheumatoid Arthritis. The number of tender joints in a standard 68 joint count was evaluated. The number of tender joints ranges from 0 tender joints to 68, where an increased number of tender joints indicates increasing level of disease severity. | Mean | Standard Deviation | joints |
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| Number of Swollen Joints | Swollen joints are an indicator of Rheumatoid Arthritis. The number of swollen joints in a standard 66 joint count was evaluated. The number of swollen joints ranges from 0 swollen joints to 66, where an increased number of swollen joints indicate increasing level of disease severity. | Mean | Standard Deviation | joints |
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| Participant Pain Assessment | The participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing "no pain" and 100 mm representing the "most pain possible". | Mean | Standard Deviation | units on a scale |
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| Physical Function (Health Assessment Questionnaire [HAQ]) | The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index. | Mean | Standard Deviation | units on a scale |
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| Physician Global Assessment | Physician Global Assessment of the participant's disease activity using a visual analog scale (VAS) of 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria. | Mean | Standard Deviation | Units on a scale |
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| Participant Global Assessment | Participants used a horizontal visual analog scale (VAS) of 100 mm for overall assessment of rheumatoid arthritis. Scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical through a horizontal line to indicate state of rheumatoid arthritis. Distance from the "very well" end of the horizontal line to the vertical line drawn by the participant was the global disease assessment score on a scale of 1-10, where 1=controlled or equivocal rheumatoid arthritis activity, 1.1-4=mild activity, 4.1-8=moderate activity, and 8.1-10=high activity. | Mean | Standard Deviation | units on a scale |
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| C-Reactive Protein (CRP) Level | CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of CRP can be used to determine DAS 28. | Mean | Standard Deviation | mg/dL |
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| Morning stiffness | Mean | Standard Deviation | minutes |
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| Rheumatoid Factor Status | Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which in itself is an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 IU/mL and considered negative if value is <20. | Number | participants |
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| Methotrexate Usage at Registration | n=9, 175, and 0 for participants from phase I study,phase II study, and new participants with MTX, respectively. | Mean | Standard Deviation | mg/week |
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| Oral Corticosteroids Usage at Registration | Dosage of oral corticosteroids was calculated using prednisolone volume. n=13, 146, and 23 for participants from phase I study, phase II study, and new participants with MTX, respectively. | Mean | Standard Deviation | mg/day |
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| 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs | AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included. | All treated participants who received at least 1 dose of the study drug. | Posted | Number | participants | From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). |
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| Secondary | Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time | ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. | All treated participants who received at least 1 dose of the study drug. n = number of participants assessed at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. |
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| Secondary | Percentage of Participants With ACR 50 Response Over Time | ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. | All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. |
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| Secondary | Percentage of Participants With ACR 70 Response Over Time | ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score. | All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192. |
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| Secondary | Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of > 5.1), low disease activity (change of ≤ 3.2) and remission (< 2.6). Please see outcome 8 for change from BL data. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point. | Posted | Mean | Standard Deviation | Units on a Scale | At BL (week 0), week 24, 48, 96, 144, and 192. |
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| Secondary | Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Please refer to outcome 7 for BL and PBL values. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point. | Posted | Mean | 95% Confidence Interval | Units on a Scale | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
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| Secondary | Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point. | Posted | Number | participants | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
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| Primary | Number of Participants With Abnormal Laboratory Changes (ALC) | The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations. | All treated participants who received at least 1 dose of the study drug. | Posted | Number | participants | From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). |
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| Secondary | Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192 | The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity. | All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point. | Posted | Number | participants | At weeks 24, 48, 96, 144, and 192. |
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| Secondary | Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 | The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score < 2.6 were considered to be in remission. | All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point. | Posted | Number | participants | At weeks 24, 48, 96, 144, and 192. |
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| Secondary | Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 | The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from BL in HAQ. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
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| Secondary | Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. | Posted | Mean | Standard Deviation | Units on a Scale | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
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| Secondary | Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. | Posted | Mean | 95% Confidence Interval | Units on a Scale | At baseline (week 0), weeks 24, 48, 96, 144, and 192. |
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| Secondary | Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores | The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. | Posted | Mean | Standard Deviation | Units on a Scale | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
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| Secondary | Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 | The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. | Posted | Mean | 95% Confidence Interval | Units on a Scale | At BL (Week 0), weeks 24, 48, 96, 144, and 192. |
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| Secondary | Baseline and Postbaseline C-reactive Protein (CRP) Levels | CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data. | All treated participants who received at least 1 dose of the study drug. n = number of participants with both BL and PBL measurement at a given point time point. | Posted | Mean | Standard Deviation | mg/dL | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
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| Secondary | Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 | CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value * 100. Please refer to outcome 17 for BL and PBL values. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. | Posted | Mean | 95% Confidence Interval | percentage improvement | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
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| Secondary | Baseline and Postbaseline Rheumatoid Factor Levels | Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please see outcome 20 for change from BL data. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. | Posted | Mean | Standard Deviation | IU/mL | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
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| Secondary | Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 | RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please refer to outcome 19 for BL and PBL values. | All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point. | Posted | Mean | 95% Confidence Interval | IU/mL | At BL (week 0), weeks 24, 48, 96, 144, and 192. |
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| Secondary | Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies | Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. | All participants who received study treatment, and had BL and at least one PBL measurement for immunogenicity. | Posted | Number | participants | At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192. |
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| Secondary | Abatacept PK Parameter: Total Body Clearance | Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism. | All participants who received abatacept and had blood samples for assay. | Posted | Median | Full Range | L/day | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
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| Secondary | Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State | Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule. | All participants who received abatacept and had blood samples for assay. | Posted | Median | Full Range | µg*h/mL | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
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| Secondary | Abatacept PK Parameter: Maximum Serum Concentration at Steady State | Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max). | All participants who received abatacept and had blood samples for assay. | Posted | Median | Full Range | µg/mL | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
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| Secondary | Abatacept PK Parameter: Minimum Plasma Concentration at Steady State | Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state. | All participants who received abatacept and had blood samples for assay. | Posted | Median | Full Range | µg/mL | Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits. |
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| Primary | Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator | All treated participants who received at least 1 dose of the study drug. | Posted | Number | participants | At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months). |
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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 | Participants From Phase I Study (IM101-034); Abatacept 10mg/kg | Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion. | 4 | 13 | 13 | 13 | ||
| EG001 | Participants From Phase II Study(IM101-071); Abatacept 10mg/kg | Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | 50 | 178 | 176 | 178 | ||
| EG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. | 14 | 26 | 24 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA Version. 13.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Radicular cyst | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Otitis media chronic | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Pharyngeal abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Head deformity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Knee deformity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Pinealoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bunion operation | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric polypectomy | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood pressure systolic decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Brain natriuretic peptide increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atlantoaxial instability | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 13.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
Not provided
Not provided
| 30 - 39 years |
|
| 40 - 49 years |
|
| 50 - 59 years |
|
| ≥ 60 years |
|
| Male |
|
| >2 to <= 5 years |
|
| > 5 to <= 10 years |
|
| > 10 years |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Positive (>20 IU/mL) |
|
| Title | Measurements |
|---|---|
|
| AEs |
|
| Drug-related AEs |
|
| Discontinuation due to SAEs |
|
| Discontinuation due to AEs |
|
| Deaths |
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 |
| New Participants With MTX Intolerance; Abatacept 10 mg/kg |
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| New Participants With MTX Intolerance; Abatacept 10 mg/kg |
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| New Participants With MTX Intolerance; Abatacept 10 mg/kg |
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| New Participants With MTX Intolerance; Abatacept 10 mg/kg |
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| New Participants With MTX Intolerance; Abatacept 10 mg/kg |
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
| OG002 | New Participants With MTX Intolerance; Abatacept 10 mg/kg | Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion. |
|
|
|
|
|
|
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|