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Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Abatacept

Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Anti-Tumor Necrosing Factor (TNF) Therapy

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Completed double-blind portion of the IM101064 study. Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis American College of Rheumatology (ACR) functional class I, II, III Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months Exclusion Criteria: Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules) History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Open-label Abatacept (ABA)-Previous User

Open-label ABA-Current User

Long-term ABA

Arm Description

In participants who have had an inadequate efficacy response or intolerance on previous TNF-antagonist therapy (off therapy for at least 2 months), open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.

In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.

Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.

Outcomes

Primary Outcome Measures

Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=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 congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug

Short-term Period: Number of Participants With AEs of Special Interest

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).

Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria

Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.

Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria

Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL

Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria

Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN

Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria

Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3

Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure

Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)

Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.

Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations

Long-term Period: Number of Participants With AEs of Special Interest

Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria

ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Marked abnormality criteria=Hemoglobin: >3 g/dL decrease from BL; Hematocrit: <0.75*BL; Erythrocytes:<0.75*BL; Platelets: <0.67*LLN/>1.5 * ULN, or if BL<LLN, use 0.5*BL/<100,000 mm^3; Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN,use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.

Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria

Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN,use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-Glutamyl transferase (GGT): >2*ULN, or if BL>ULN, use >3*BL; bilirubin: >2*ULN, or if BL>ULN, use >4*BL; blood urea nitrogen (BUN): >2*BL; creatinine: >1.5*BL

Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria

Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria

Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time

HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL

Long-term Period: Change From Baseline in Hematocrit Over Time

The hematocrit value refers to the percentage of blood volume that is occupied by red blood cells. Hematocrit values for participants were expressed as percentages and were averaged to yield a group mean value (percentage) at a particular time point. The mean change from baseline in hematocrit value (expressed as a percent)= mean post-baseline value (expressed as a percent) - mean baseline value (expressed as a percent).

Long-term Period: Change From Baseline in Erythrocytes Over Time

Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL

Long-term Period: Change From Baseline in Platelets (PLT) Over Time

Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL

Long-term Period: Change From Baseline in White Blood Cells Over Time

Leukocytes NR=4.1 - 12.3*10^3 c/uL, MA is <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN. Neutrophils+bands MA is <1.0 * 10^3 c/uL. Eosinophils MA is >0.750 * 10^3 c/uL. Basophils MA is > 400 mm^3. Monocytes MA is >2000 mm^3. Lymphocytes MA is <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL

Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time

Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time

Bilirubin NR=0.2-1.2 mg/dL, MA: >2* ULN, or if BL>ULN then use >4* BL. BUN NR=4.0-24.0 mg/dL, MA: >2*BL. Creatinine NR=0.4-1.2 mg/dL, MA: >1.5*BL. Ca NR=8.8-10.2 mg/dL, MA: <0.8*LLN/>1.2*ULN, or if BL<LLN then use 0.75*BL or >ULN, or if BL>ULN then use>1.25*BL or <LLN. P NR=2.8-4.0 mg/dL, MA: <0.75*LLN/ >1.25*ULN, or if BL<LLN then use 0.67*BL or >ULN, or if BL>ULN then use>1.33*BL or <LLN. Glu MA: <65 mg/dL/ >220 mg/dL. Uric acid MA: >1.5*ULN, or if BL>ULN then use >2*BL.

LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time

Na NR=132 - 147 mEq/L, MA is 95* LLN/ >1.05* ULN, or if BL<LLN then use 0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN. K NR=3.3 - 5.5 mEq/L, MA is <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN. Cl NR=94 - 111 mEq/L, MA is <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN

Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time

Measurements were taken in a seated position before and after abatacept infusion.

Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time

Measurements were taken in a seated position before and after abatacept infusion.

Long-term Period: Mean Heart Rate (HR) Over Time

Long-term Period: Mean Temperature (T) Over Time

Secondary Outcome Measures

Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169

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, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.

Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label

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, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label

The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with measurements available at that post-BL visit.

Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP)

hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28.

Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF)

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.

Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI)

The HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain 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. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do).

Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response

HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain 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. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.

Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores

The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.

Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores

Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS)

Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS)

Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time

The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.

Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term

The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0)values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term

The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL(Day 0)value for only that cohort of participants with measurements available at that post-BL visit.

Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term

The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term

The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.

Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term

The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term

The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.

Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term

hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term

hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.

Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term

The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term

The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched mean change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with data available at that post-BL visit.

Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term

HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising,eating,walking, hygiene, reach, grip and common activities. Domain 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. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched BL(Day 0)values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.

Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term

HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Domain 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. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0(no difficulty), max overall score=3(unable to do). Post-BL values presented for each visit represent only that cohort of participants with measurements available at that post-BL visit.

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term

HAQ-DI includes 20 questions assessing physical functions in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Domain questions evaluated on 4-point scale: 0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=sum of worst scores in each domain ÷ number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-BL visit.

Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time

Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term

SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health;(2) mental component summary=vitality,social functioning,role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score and 100=best score. Time-matched BL (Day 0) values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit

Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term

SF-36 measures health-related quality of life and has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Post-BL values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term

SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-baseline visit.

LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA

Full Information

NCT ID

NCT00124982

First Posted

June 30, 2005

Last Updated

February 23, 2012

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00124982

Brief Title

Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

Official Title

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1286 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open-label Abatacept (ABA)-Previous User

Arm Type

Experimental

Arm Description

Arm Title

Open-label ABA-Current User

Arm Type

Experimental

Arm Description

Arm Title

Long-term ABA

Arm Type

Experimental

Arm Description

Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.

Intervention Type

Drug

Intervention Name(s)

Abatacept

Other Intervention Name(s)

Orencia

Intervention Description

IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.

Intervention Type

Drug

Intervention Name(s)

Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Intervention Description

During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).

Intervention Type

Drug

Intervention Name(s)

Anti-Tumor Necrosing Factor (TNF) Therapy

Intervention Description

Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months

Primary Outcome Measure Information:

Title

Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations

Description

Time Frame

Days 1-169

Title

Short-term Period: Number of Participants With AEs of Special Interest

Description

Time Frame

Days 1-169

Title

Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria

Description

Time Frame

Days 1-169

Title

Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria

Description

Time Frame

Days 1-169

Title

Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria

Description

Time Frame

Days 1-169

Title

Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria

Description

Time Frame

Days 1-169

Title

Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure

Time Frame

Day 1 (Baseline) -Day 169

Title

Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)

Description

Time Frame

Days 1-169

Title

Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations

Description

Time Frame

From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept

Title

Long-term Period: Number of Participants With AEs of Special Interest

Description

Time Frame

From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept

Title

Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria

Description

Time Frame

From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept

Title

Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria

Description

Time Frame

From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept

Title

Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria

Description

Time Frame

From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept

Title

Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria

Description

Time Frame

From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept

Title

Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time

Description

Time Frame

BL, Day 365, Day 729

Title

Long-term Period: Change From Baseline in Hematocrit Over Time

Description

Time Frame

BL, Day 365, Day 729

Title

Long-term Period: Change From Baseline in Erythrocytes Over Time

Description

Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL

Time Frame

BL, Day 365, Day 729

Title

Long-term Period: Change From Baseline in Platelets (PLT) Over Time

Description

Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL

Time Frame

BL, Day 365, Day 729

Title

Long-term Period: Change From Baseline in White Blood Cells Over Time

Description

Time Frame

BL, Day 365, Day 729

Title

Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time

Description

Time Frame

BL, Day 365, Day 729

Title

Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time

Description

Time Frame

BL, Day 365, Day 729

Title

LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time

Description

Time Frame

BL, Day 365, Day 729

Title

Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time

Description

Measurements were taken in a seated position before and after abatacept infusion.

Time Frame

From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept

Title

Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time

Description

Measurements were taken in a seated position before and after abatacept infusion.

Time Frame

From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept

Title

Long-term Period: Mean Heart Rate (HR) Over Time

Time Frame

From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept

Title

Long-term Period: Mean Temperature (T) Over Time

Time Frame

From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept

Secondary Outcome Measure Information:

Title

Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169

Description

Time Frame

BL, Day 169

Title

Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label

Description

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, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

Time Frame

BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Title

Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label

Description

The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with measurements available at that post-BL visit.

Time Frame

BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Title

Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP)

Description

hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28.

Time Frame

BL, Day 169

Title

Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF)

Description

Time Frame

BL, Day 169

Title

Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI)

Description

Time Frame

BL, Day 169

Title

Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response

Description

Time Frame

BL, Day 169

Title

Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores

Description

Time Frame

Title

Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores

Description

Time Frame

BL, Day 169

Title

Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS)

Description

Time Frame

Title

Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS)

Description

Time Frame

BL, Day 169

Title

Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time

Description

The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.

Time Frame

BL, Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term

Description

The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0)values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term

Description

The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL(Day 0)value for only that cohort of participants with measurements available at that post-BL visit.

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term

Description

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term

Description

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term

Description

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term

Description

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term

Description

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term

Description

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term

Description

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term

Description

The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched mean change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with data available at that post-BL visit.

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term

Description

Time Frame

BL (Day 0)

Title

Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term

Description

HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Domain 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. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0(no difficulty), max overall score=3(unable to do). Post-BL values presented for each visit represent only that cohort of participants with measurements available at that post-BL visit.

Time Frame

Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term

Description

Time Frame

BL (Day 0), Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time

Description

Time Frame

BL, Days 365, 449, 533, 617, 729, 813

Title

Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term

Description

Time Frame

BL (Day 0)

Title

Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term

Description

Time Frame

Days 365 and 729

Title

Description

SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-baseline visit.

Time Frame

BL (Day 0), Days 365, 729

Title

LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA

Description

Time Frame

Days 1-813

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

Local Institution

City

Huntsville

State/Province

Alabama

Country

United States

Facility Name

Local Institution

City

Paradise Valley

State/Province

Arizona

Country

United States

Facility Name

Local Institution

City

Peoria

State/Province

Arizona

Country

United States

Facility Name

Local Institution

City

Tucson

State/Province

Arizona

Country

United States

Facility Name

Local Institution

City

Long Beach

State/Province

California

Country

United States

Facility Name

Local Institution

City

Palm Springs

State/Province

California

Country

United States

Facility Name

Local Institution

City

Palo Alto

State/Province

California

Country

United States

Facility Name

Local Institution

City

San Diego

State/Province

California

Country

United States

Facility Name

Local Institution

City

Santa Monica

State/Province

California

Country

United States

Facility Name

Local Institution

City

Colorado Springs

State/Province

Colorado

Country

United States

Facility Name

Local Institution

City

Denver

State/Province

Colorado

Country

United States

Facility Name

Local Institution

City

Danbury

State/Province

Connecticut

Country

United States

Facility Name

Local Institution

City

Hamden

State/Province

Connecticut

Country

United States

Facility Name

Local Institution

City

Trumbull

State/Province

Connecticut

Country

United States

Facility Name

Local Institution

City

Washington

State/Province

District of Columbia

Country

United States

Facility Name

Local Institution

City

Aventura

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Clearwater

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Ft. Lauderdale

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Jupiter

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Largo

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Sarasota

State/Province

Florida

Country

United States

Facility Name

Local Institution

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

Local Institution

City

Blue Ridge

State/Province

Georgia

Country

United States

Facility Name

Local Institution

City

Macon

State/Province

Georgia

Country

United States

Facility Name

Local Institution

City

Morton Grove

State/Province

Illinois

Country

United States

Facility Name

Local Institution

City

Evansville

State/Province

Indiana

Country

United States

Facility Name

Local Institution

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

Local Institution

City

Des Moines

State/Province

Iowa

Country

United States

Facility Name

Local Institution

City

Kansas City

State/Province

Kansas

Country

United States

Facility Name

Local Institution

City

Prairie Village

State/Province

Kansas

Country

United States

Facility Name

Local Institution

City

Bowling Green

State/Province

Kentucky

Country

United States

Facility Name

Local Institution

City

Louisville

State/Province

Kentucky

Country

United States

Facility Name

Local Institution

City

New Orleans

State/Province

Louisiana

Country

United States

Facility Name

Local Institution

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

Local Institution

City

Peabody

State/Province

Massachusetts

Country

United States

Facility Name

Local Institution

City

Springfield

State/Province

Massachusetts

Country

United States

Facility Name

Local Institution

City

Worcester

State/Province

Massachusetts

Country

United States

Facility Name

Local Institution

City

Ann Arbor

State/Province

Michigan

Country

United States

Facility Name

Local Institution

City

East Lansing

State/Province

Michigan

Country

United States

Facility Name

Local Institution

City

Grand Rapids

State/Province

Michigan

Country

United States

Facility Name

Local Institution

City

Lansing

State/Province

Michigan

Country

United States

Facility Name

Local Institution

City

Petockey

State/Province

Michigan

Country

United States

Facility Name

Local Institution

City

Minneapolis

State/Province

Minnesota

Country

United States

Facility Name

Local Institution

City

St. Paul

State/Province

Minnesota

Country

United States

Facility Name

Local Institution

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

Local Institution

City

Las Vegas

State/Province

Nevada

Country

United States

Facility Name

Local Institution

City

Lebanon

State/Province

New Hampshire

Country

United States

Facility Name

Local Institution

City

Nashua

State/Province

New Hampshire

Country

United States

Facility Name

Local Institution

City

Cherry Hill

State/Province

New Jersey

Country

United States

Facility Name

Local Institution

City

Dover

State/Province

New Jersey

Country

United States

Facility Name

Local Institution

City

Manalapan

State/Province

New Jersey

Country

United States

Facility Name

Local Institution

City

New Brunswick

State/Province

New Jersey

Country

United States

Facility Name

Local Institution

City

Somerset

State/Province

New Jersey

Country

United States

Facility Name

Local Institution

City

Teaneck

State/Province

New Jersey

Country

United States

Facility Name

Local Institution

City

Voorhees

State/Province

New Jersey

Country

United States

Facility Name

Local Institution

City

Albany

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Brooklyn

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Hewlett

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Lake Success

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Mineola

State/Province

New York

Country

United States

Facility Name

Local Institution

City

New York

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Olean

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Orchard Park

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Rochester

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Schenectady

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Smithtown

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Syracuse

State/Province

New York

Country

United States

Facility Name

Local Institution

City

Asheville

State/Province

North Carolina

Country

United States

Facility Name

Local Institution

City

Charlotte

State/Province

North Carolina

Country

United States

Facility Name

Local Institution

City

Hickory

State/Province

North Carolina

Country

United States

Facility Name

Local Institution

City

Wilmington

State/Province

North Carolina

Country

United States

Facility Name

Local Institution

City

Bismark

State/Province

North Dakota

Country

United States

Facility Name

Local Institution

City

Akron

State/Province

Ohio

Country

United States

Facility Name

Local Institution

City

Beachwood

State/Province

Ohio

Country

United States

Facility Name

Local Institution

City

Cleveland

State/Province

Ohio

Country

United States

Facility Name

Local Institution

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

Local Institution

City

Mayfield Village

State/Province

Ohio

Country

United States

Facility Name

Local Institution

City

Youngstown

State/Province

Ohio

Country

United States

Facility Name

Local Institution

City

Portland

State/Province

Oregon

Country

United States

Facility Name

Local Institution

City

Bala Cynwyd

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Bethlehem

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Camp Hill

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Duncansville

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Erie

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Meadville

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

West Reading

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Wexford

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Willow Grove

State/Province

Pennsylvania

Country

United States

Facility Name

Local Institution

City

Providence

State/Province

Rhode Island

Country

United States

Facility Name

Local Institution

City

Myrtle Beach

State/Province

South Carolina

Country

United States

Facility Name

Local Institution

City

Simpsonville

State/Province

South Carolina

Country

United States

Facility Name

Local Institution

City

Sioux Falls

State/Province

South Dakota

Country

United States

Facility Name

Local Institution

City

Hixson

State/Province

Tennessee

Country

United States

Facility Name

Local Institution

City

Knoxville

State/Province

Tennessee

Country

United States

Facility Name

Local Institution

City

Austin

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

Corpus Christi

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

Galveston

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

Houston

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

Lubbock

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

Sugarland

State/Province

Texas

Country

United States

Facility Name

Local Institution

City

Burke

State/Province

Virginia

Country

United States

Facility Name

Local Institution

City

Chesapeake

State/Province

Virginia

Country

United States

Facility Name

Local Institution

City

Fairfax

State/Province

Virginia

Country

United States

Facility Name

Local Institution

City

Salem

State/Province

Virginia

Country

United States

Facility Name

Local Institution

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Local Institution

City

Vancouver

State/Province

Washington

Country

United States

Facility Name

Local Institution

City

Glendale

State/Province

Wisconsin

Country

United States

Facility Name

Local Institution

City

La Crosse

State/Province

Wisconsin

Country

United States

Facility Name

Local Institution

City

Madison

State/Province

Wisconsin

Country

United States

Facility Name

Local Institution

City

Bruxelles

Country

Belgium

Facility Name

Local Institution

City

Leuven

Country

Belgium

Facility Name

Local Institution

City

Prague 2

Country

Czech Republic

Facility Name

Local Institution

City

Boisguillaume

Country

France

Facility Name

Local Institution

City

Bordeaux Cedex

Country

France

Facility Name

Local Institution

City

Brest Cedex

Country

France

Facility Name

Local Institution

City

Chambray Les Tours

Country

France

Facility Name

Local Institution

City

Montpellier

Country

France

Facility Name

Local Institution

City

Nice Cedex 03

Country

France

Facility Name

Local Institution

City

Paris

Country

France

Facility Name

Local Institution

City

Rennes Cedex 9

Country

France

Facility Name

Local Institution

City

Strasbourg Cedex

Country

France

Facility Name

Local Institution

City

Toulouse

Country

France

Facility Name

Local Institution

City

Freiburg

Country

Germany

Facility Name

Local Institution

City

Hamburg

Country

Germany

Facility Name

Local Institution

City

Kiel

Country

Germany

Facility Name

Local Institution

City

Leipzig

Country

Germany

Facility Name

Local Institution

City

Tuebingen

Country

Germany

Facility Name

Local Institution

City

Cork

Country

Ireland

Facility Name

Local Institution

City

Genova

Country

Italy

Facility Name

Local Institution

City

Milano

Country

Italy

Facility Name

Local Institution

City

Torino

Country

Italy

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

Country

Mexico

Facility Name

Local Institution

City

Distrito Federal

Country

Mexico

Facility Name

Local Institution

City

Alicante

Country

Spain

Facility Name

Local Institution

City

Barcelona

Country

Spain

Facility Name

Local Institution

City

Guipuzcoa

Country

Spain

Facility Name

Local Institution

City

Madrid

Country

Spain

Facility Name

Local Institution

City

Santander

Country

Spain

Facility Name

Local Institution

City

Valencia

Country

Spain

Facility Name

Local Institution

City

Cambridge

State/Province

Cambridgeshire

Country

United Kingdom

Facility Name

Local Institution

City

Manchester

State/Province

Greater Manchester

Country

United Kingdom

Facility Name

Local Institution

City

Maidstone

State/Province

Kent

Country

United Kingdom

Facility Name

Local Institution

City

Leeds

State/Province

North Yorkshire

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

19074911

Citation

Schiff M, Pritchard C, Huffstutter JE, Rodriguez-Valverde V, Durez P, Zhou X, Li T, Bahrt K, Kelly S, Le Bars M, Genovese MC. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis. 2009 Nov;68(11):1708-14. doi: 10.1136/ard.2008.099218. Epub 2008 Dec 15.

Results Reference

background

PubMed Identifier

29329602

Citation

Alten R, Burkhardt H, Feist E, Kruger K, Rech J, Rubbert-Roth A, Voll RE, Elbez Y, Rauch C. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting. Arthritis Res Ther. 2018 Jan 2;20(1):1. doi: 10.1186/s13075-017-1488-5.

Results Reference

derived

PubMed Identifier

27889300

Citation

Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

Results Reference

derived

PubMed Identifier

18402714

Citation

Hassett AL, Li T, Buyske S, Savage SV, Gignac MA. The multi-faceted assessment of independence in patients with rheumatoid arthritis: preliminary validation from the ATTAIN study. Curr Med Res Opin. 2008 May;24(5):1443-53. doi: 10.1185/030079908x297376. Epub 2008 Apr 9.

Results Reference

derived

PubMed Identifier

17921185

Citation

Genovese MC, Schiff M, Luggen M, Becker JC, Aranda R, Teng J, Li T, Schmidely N, Le Bars M, Dougados M. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Ann Rheum Dis. 2008 Apr;67(4):547-54. doi: 10.1136/ard.2007.074773. Epub 2007 Oct 5.

Results Reference

derived

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Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial