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Methotrexate-Inadequate Response Study

Primary Purpose

Rheumatoid Arthritis (RA)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Subcutaneous (SC) Abatacept

Intravenous (IV) Abatacept

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis (RA)

Eligibility Criteria

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Subjects who are considered methotrexate inadequate responders
10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)

Exclusion Criteria:

Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies
Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous)
Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
Subjects with severe chronic or recurrent bacterial infections
Subjects who have received treatment with rituximab

An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Subcutaneous (SC) Abatacept

Intravenous (IV) Abatacept

Arm Description

Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.

Outcomes

Primary Outcome Measures

Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169

The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).

Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population

Serum samples from all treated adult participants with active rheumatoid arthritis who were from the Anti-TNF failure population were screened for the presence of drug-specific antibodies using Enzyme Linked Immunoabsorbant Assay (ELISA). The number of participants who had the presence of anti-abatacept antibodies or anti-CTLA-4 antibodies present in their serum are summarized.

Secondary Outcome Measures

Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169

The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.

Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169

The disability section of the full HAQ-DI 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.

Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI

The HAQ-DI includes 20 questions to assess physical function 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, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0.

Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169

The disability section of the full HAQ-DI 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-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI.

Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation

AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this 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. Treatment-related SAE=possibly, probably, or certainly related to study drug

Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died

Double-blind Period: Number of Participants With AEs of Special Interest

AE=any new untoward medical occurrence or worsening of a preexisting medical condition that 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: all infections,serious infections,and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (prespecified AEs occurring within 1 hr of start of infusion), peri-infusional AEs (prespecified AEs occurring within 24 hrs of the start of infusion), system injection reactions, and local injection site reactions

Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements

Vital sign measurements were performed for participants before and after infusion/subcutaneous injection of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.

Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality

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 and <100,000 mm^3; leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN use <0.8*BL or >ULN, or if BL>ULN, use >1.2*BL or <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.

Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality

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: >2* BL; creatinine: >1.5*BL

Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality

Marked abnormality criteria: Sodium: <0.95*LLN/>1.05*ULN, or if BL<LLN, use <0.95* BL or >ULN, or if BL>ULN, use>1.05* BL or <LLN; potassium: <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN, use>1.1* BL or <LLN; chlorine: <0.9*LLN/>1.1* ULN, or if BL<LLN, use <0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN; calcium: <0.8* LLN/>1.2* ULN, or if BL<LLN, use <0.75*BL or >ULN, or if BL>ULN, use>1.25* BL or <LLN; phosphorous: <0.75* LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33* BL or <LLN

Double-blind Period: Minimum Observed Serum Concentration of Abatacept

Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept

Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in μg/mL. Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169.

Double-blind Period: Maximum Observed Serum Concentration of Abatacept

Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept

Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. Cmax was measured in micrograms per milliliter (μg/mL).

Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept

Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept

Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) was measured as μg*h/mL. Samples for AUC (TAU) were obtained on Days 113, 120, 127, 134, and 141.

Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA)

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

Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period

C-reactive protein is an acute phase reactant protein that is a clinical marker for rheumatoid arthritis. Time-matched median percent change from baseline= (time-matched baseline value - Post-baseline value)/time-matched baseline value*100, where the time-matched baseline value represents the median baseline value for only that cohort of participants with measurements available at that visit.

Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized

An electrochemiluminescence immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; abatacept molecule). Ig and/or Junction (JNCT) category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a postbaseline titer higher than Baseline, or any postbaseline positivity if Baseline value was missing. Trt=treatment.

Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline

Rheumatoid factor (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.

Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821

Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821

Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821

The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. A clinically significant response= decrease in DAS28 score of >1.2 from baseline.

Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821

Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821

Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821

The disability section of the full HAQ includes 20 questions to assess physical function 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, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0. HAQ response was defined as an improvement (reduction) from baseline (Day 1) of at least 0.3 units in the HAQ score.

Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation

Open-Label LT Period: Number of Participants With AEs of Special Interest

AE=any new untoward medical occurrence or worsening of a preexisting medical condition that 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: all infections, serious infections, and opportunistic infections; autoimmune disorders; malignancies; system injection reactions, and local injection site reactions.

Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements

Vital sign assessments were performed in the LT period at 12-week intervals and at a yearly visit (at 16-week intervals) and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Vital signs included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.

Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities

Laboratory assessments were performed in the LT period at 12-week intervals and at a yearly visit and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Abnormalities were determined to be clinically significant by the investigator.

Full Information

NCT ID

NCT00559585

First Posted

November 15, 2007

Last Updated

November 5, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00559585

Brief Title

Methotrexate-Inadequate Response Study

Official Title

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

6. Conditions and Keywords

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

Rheumatoid Arthritis (RA)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2492 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subcutaneous (SC) Abatacept

Arm Type

Active Comparator

Arm Description

Arm Title

Intravenous (IV) Abatacept

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Subcutaneous (SC) Abatacept

Other Intervention Name(s)

Orencia, BMS-188667

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Intravenous (IV) Abatacept

Other Intervention Name(s)

Orencia, BMS-188667

Intervention Description

Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). 500mg (for body weight up to 60 kg) 750 mg (body weight between 61 and 100 kg) 1g (body weight above 100 kg)infusions

Primary Outcome Measure Information:

Title

Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169

Description

Time Frame

Day 169

Title

Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population

Description

Time Frame

Days 85, and 169 and postvisits on Days 28, 56, and 85

Secondary Outcome Measure Information:

Title

Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169

Description

Time Frame

Day 169

Title

Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169

Description

Time Frame

Day 169

Title

Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI

Description

Time Frame

Baseline to Day 169

Title

Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169

Description

The disability section of the full HAQ-DI 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-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI.

Time Frame

Day 169

Title

Description

Time Frame

Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.

Title

Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died

Description

Time Frame

Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.

Title

Double-blind Period: Number of Participants With AEs of Special Interest

Description

Time Frame

Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first.

Title

Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements

Description

Time Frame

Day 1 through end of short-term period (Day 169)

Title

Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality

Description

Time Frame

Day 1 through end of short-term period (Day 169)

Title

Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality

Description

Time Frame

Day 1 through end of short-term period (Day 169)

Title

Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality

Description

Time Frame

Day 1 through end of short-term period (Day 169)

Title

Double-blind Period: Minimum Observed Serum Concentration of Abatacept

Time Frame

Days 57, 85, 113, 120, 127, 134, 141, and 169

Title

Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept

Description

Time Frame

Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period)

Title

Double-blind Period: Maximum Observed Serum Concentration of Abatacept

Time Frame

End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous

Title

Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept

Description

Time Frame

End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous

Title

Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept

Time Frame

Dosing interval between Days 113 and 141 (TAU=28 days)

Title

Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept

Description

Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) was measured as μg*h/mL. Samples for AUC (TAU) were obtained on Days 113, 120, 127, 134, and 141.

Time Frame

Dosing Interval between Days 113 and 141 (TAU=28 days)

Title

Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA)

Description

Time Frame

Days 85, and 169 and postvisits on Days 28, 56, and 85

Title

Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period

Description

Time Frame

Baseline to Days 15, 29, 57, 85, 113, 141, and 169

Title

Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized

Description

Time Frame

Days 85, and 169 and postvisits on Days 28, 56, and 85

Title

Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline

Description

Time Frame

Baseline to Day 169

Title

Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821

Description

Time Frame

Days 169, 729, 1261, 1821

Title

Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821

Description

Time Frame

Days 169, 729, 1261, 1821

Title

Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821

Description

Time Frame

Days 169, 729, 1261, 1821

Title

Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821

Description

Time Frame

Days 169, 729, 1261, 1821

Title

Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821

Description

Time Frame

Days 169, 729, 1261, 1821

Title

Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821

Description

Time Frame

Days 169, 729, 1261, 1821

Title

Description

Time Frame

End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)

Title

Open-Label LT Period: Number of Participants With AEs of Special Interest

Description

AE=any new untoward medical occurrence or worsening of a preexisting medical condition that 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: all infections, serious infections, and opportunistic infections; autoimmune disorders; malignancies; system injection reactions, and local injection site reactions.

Time Frame

End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)

Title

Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements

Description

Time Frame

End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)

Title

Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities

Description

Time Frame

End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Subjects who are considered methotrexate inadequate responders 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count) Exclusion Criteria: Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous) Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules) Subjects with severe chronic or recurrent bacterial infections Subjects who have received treatment with rituximab An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.

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

Rheumatology Associates, Pc

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Coastal Clinical Research, Inc

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Advanced Arthritis Care & Research

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Catalina Pointe Clinical Research, Inc.

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

St. Joseph'S Mercy Clinic

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

Talbert Medical Group

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92646

Country

United States

Facility Name

Allergy & Rheumatology Medical Clinic, Inc.

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Valerius Medical Group &Research Ctr. Of Greater Long Beach

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Stanford University School Of Medicine

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

San Diego Arthritis Medical Clinic

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Boulder Medical Center

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

Arthritis Assoc And Osteo Ctr Of Col Sprgs

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80910

Country

United States

Facility Name

Denver Arthritis Clinic

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Arthritis Center Of The Rockies, Pc

City

Loveland

State/Province

Colorado

ZIP/Postal Code

80538

Country

United States

Facility Name

Guadagnoli, Germano

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606

Country

United States

Facility Name

Joao Nascimento

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606

Country

United States

Facility Name

Clinical Research Center Of Ct/Ny

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Arthritis And Rheumatic Disease Specialties

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Arthritis & Osteoporosis Treatment Center, Pa

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Facility Name

Rheumatology Associates Of Central Florida

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

The Arthritis Center

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Sarasota Arthritis Research Center

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Arthritis & Rheumatology Of Georgia,Pc

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Boise Rheumatology/ Intermountain Research Center, Inc

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Coeur D'Alene Arthrit Clin

City

Coeur D Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Quincy Medical Group

City

Quincy

State/Province

Illinois

ZIP/Postal Code

62301

Country

United States

Facility Name

Rockford Orthopedic Associates, Ltd.

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61107

Country

United States

Facility Name

The Arthritis Center

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Klein And Associates, M.D., Pa

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

Clinical Pharmacology Study Group

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01610

Country

United States

Facility Name

Shores Rheumatology, P. C.

City

St. Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

Arthritis Assoicates Of Mississippi

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Kansas City Internal Medicine

City

Lee'S Summit

State/Province

Missouri

ZIP/Postal Code

64086

Country

United States

Facility Name

Physician Research Collaboration, Llc

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Allergy And Arthritis Associates

City

Dover

State/Province

New Jersey

ZIP/Postal Code

07801

Country

United States

Facility Name

Albuquerque Clinical Trials, Inc.

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Albuquerque Rehabilitation & Rheumatology Pc

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

The Center For Rheumatology, Llp

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Southern Tier Arthritis & Rheumatism

City

Olean

State/Province

New York

ZIP/Postal Code

14760

Country

United States

Facility Name

Arthritis Health Associates

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Asheville Rheumatology & Osteoporosis Research Asso P. A.

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

The Arthritis Clinic & Carolina Bone & Joint

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Rheumatology

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

Physicians East, Pa

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Carolina Pharmaceutical Research

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28625

Country

United States

Facility Name

Carolina Arthritis Associates

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Cincinnati Rheumatic Disease Study Group

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Health Research Of Oklahoma

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Oklahoma Center For Arthritis Therapy And Research

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

Country

United States

Facility Name

Healthcare Research Consultants

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

Pro Research

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Portland Rheumatology Clinic, Llc

City

Lake Oswego

State/Province

Oregon

ZIP/Postal Code

97035

Country

United States

Facility Name

East Penn Rheumatology Associates

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Rheumatology Associates

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Low Country Rheumatology, Pa

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Columbia Arthritis Center

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Carolina Health Specialists

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

Acme Research, Llc

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Arthritis Clinic

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Rheumatology Consultants Pllc

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

The Arthritis Group, Pc

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38104

Country

United States

Facility Name

St. Thomas Hospital Tower East

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Walter F. Chase

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Rheumatic Disease Clinical Research Center, Llc

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Accurate Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Texas Research Center

City

Sugarland

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Arthritis Clinic Of Northern Virginia, P.C.

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22205

Country

United States

Facility Name

Center For Arthritis & Rheumatic Diseases, Pc

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

South Puget Sound Clinincal Research Center

City

Olympia

State/Province

Washington

ZIP/Postal Code

98502

Country

United States

Facility Name

Tacoma Center For Arthritis Research Ps

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Local Institution

City

Ciudad Autonoma

State/Province

Buenos Aires

ZIP/Postal Code

CP1425A WC

Country

Argentina

Facility Name

Local Institution

City

Rosario, Santa Fe

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

1015

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1428DQG

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution

City

Cordoba

ZIP/Postal Code

5016

Country

Argentina

Facility Name

Local Institution

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Local Institution

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Local Institution

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Local Institution

City

Cairns

State/Province

Queensland

ZIP/Postal Code

QLD 4870

Country

Australia

Facility Name

Local Institution

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Local Institution

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Local Institution

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

Local Institution

City

Shenton Park

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Local Institution

City

Bruxelles

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Local Institution

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Local Institution

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Local Institution

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Local Institution

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Local Institution

City

Goiania

State/Province

Goias

ZIP/Postal Code

74110

Country

Brazil

Facility Name

Local Institution

City

Goiania

State/Province

Goias

ZIP/Postal Code

74605

Country

Brazil

Facility Name

Local Institution

City

Juiz De Fora

State/Province

Minas Gerais

ZIP/Postal Code

36010

Country

Brazil

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80060240

Country

Brazil

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80440

Country

Brazil

Facility Name

Local Institution

City

Recife

State/Province

Pernambuco

ZIP/Postal Code

50670

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035003

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

91610

Country

Brazil

Facility Name

Local Institution

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13059

Country

Brazil

Facility Name

Local Institution

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13083

Country

Brazil

Facility Name

Local Institution

City

Rio De Janeiro

ZIP/Postal Code

20551

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

04027

Country

Brazil

Facility Name

Local Institution

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

Local Institution

City

St. John'S

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 5E8

Country

Canada

Facility Name

Local Institution

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

Local Institution

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 2B6

Country

Canada

Facility Name

Local Institution

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2V8

Country

Canada

Facility Name

Local Institution

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 1A2

Country

Canada

Facility Name

Local Institution

City

Ste-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Local Institution

City

Ste-Foy

State/Province

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

Local Institution

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Local Institution

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

Local Institution

City

Santiago De Chile

State/Province

Metropolitana

ZIP/Postal Code

Country

Chile

Facility Name

Local Institution

City

Santiago De Chile

State/Province

Metropolitana

Country

Chile

Facility Name

Local Institution

City

Santiago

State/Province

Metropolitana

ZIP/Postal Code

7500995

Country

Chile

Facility Name

Local Institution

City

Santiago

State/Province

Metropolitana

Country

Chile

Facility Name

Local Institution

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Local Institution

City

Brest Cedex

ZIP/Postal Code

29609

Country

France

Facility Name

Local Institution

City

Chambray Les Tours

ZIP/Postal Code

37170

Country

France

Facility Name

Local Institution

City

Le Mans

ZIP/Postal Code

72037

Country

France

Facility Name

Local Institution

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Local Institution

City

Marseille

ZIP/Postal Code

13008

Country

France

Facility Name

Local Institution

City

Nice Cedex 3

ZIP/Postal Code

06202

Country

France

Facility Name

Local Institution

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Local Institution

City

Paris Cedex 14

ZIP/Postal Code

75679

Country

France

Facility Name

Local Institution

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

Local Institution

City

Strasbourg Cedex

ZIP/Postal Code

67098

Country

France

Facility Name

Local Institution

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Local Institution

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Local Institution

City

Muenchen

ZIP/Postal Code

81541

Country

Germany

Facility Name

Local Institution

City

Munchen

ZIP/Postal Code

80639

Country

Germany

Facility Name

Local Institution

City

Heraklion Crete

ZIP/Postal Code

71110

Country

Greece

Facility Name

Local Institution

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Local Institution

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

Local Institution

City

Secunderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500003

Country

India

Facility Name

Local Institution

City

Navrangpura, Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380009

Country

India

Facility Name

Local Institution

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 034

Country

India

Facility Name

Local Institution

City

Bangalore

ZIP/Postal Code

560003

Country

India

Facility Name

Local Institution

City

Hyderabad

ZIP/Postal Code

500004

Country

India

Facility Name

Local Institution

City

Lucknow

ZIP/Postal Code

226014

Country

India

Facility Name

Local Institution

City

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Local Institution

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Local Institution

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Local Institution

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Local Institution

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Local Institution

City

Seoul

State/Province

Sungdong-Gu

ZIP/Postal Code

133-792

Country

Korea, Republic of

Facility Name

Local Institution

City

Daegu

ZIP/Postal Code

705-718

Country

Korea, Republic of

Facility Name

Local Institution

City

Daejeon

ZIP/Postal Code

302-799

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

137-040

Country

Korea, Republic of

Facility Name

Local Institution

City

Tijuana

State/Province

Baja California

ZIP/Postal Code

22320

Country

Mexico

Facility Name

Local Institution

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44100

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44620

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44690

Country

Mexico

Facility Name

Local Institution

City

Morelia

State/Province

Michioacan

ZIP/Postal Code

58270

Country

Mexico

Facility Name

Local Institution

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97000

Country

Mexico

Facility Name

Local Institution

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Local Institution

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Local Institution

City

Nuevo Leon

ZIP/Postal Code

64020

Country

Mexico

Facility Name

Local Institution

City

Queretaro

ZIP/Postal Code

76178

Country

Mexico

Facility Name

Local Institution

City

San Luis Potosi

ZIP/Postal Code

78240

Country

Mexico

Facility Name

Local Institution

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Local Institution

City

Callao

ZIP/Postal Code

CALLAO 2

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

LIMA 13

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

LIMA 27

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

LIMA 33

Country

Peru

Facility Name

Local Institution

City

Bialystok

ZIP/Postal Code

15-337

Country

Poland

Facility Name

Local Institution

City

Bialystok

ZIP/Postal Code

15-461

Country

Poland

Facility Name

Local Institution

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Local Institution

City

Konskie

ZIP/Postal Code

26-200

Country

Poland

Facility Name

Local Institution

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Local Institution

City

Poznan

ZIP/Postal Code

60-218

Country

Poland

Facility Name

Local Institution

City

Poznan

ZIP/Postal Code

60773

Country

Poland

Facility Name

Local Institution

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

02-777

Country

Poland

Facility Name

Local Institution

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

129327

Country

Russian Federation

Facility Name

Local Institution

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Local Institution

City

Kempton Park

State/Province

Gauteng

ZIP/Postal Code

1619

Country

South Africa

Facility Name

Local Institution

City

Muckleneuk

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Local Institution

City

Muckleneuk

State/Province

Gauteng

ZIP/Postal Code

0132

Country

South Africa

Facility Name

Local Institution

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0083

Country

South Africa

Facility Name

Local Institution

City

Durban

State/Province

Kwa Zulu Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Local Institution

City

Panorama

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Local Institution

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Local Institution

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

Local Institution

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Local Institution

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Facility Name

Local Institution

City

Denizli

ZIP/Postal Code

20070

Country

Turkey

Facility Name

Local Institution

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

Local Institution

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

Local Institution

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 2QQ

Country

United Kingdom

Facility Name

Local Institution

City

Bridgend

State/Province

Glamorgan

ZIP/Postal Code

CF31 1RQ

Country

United Kingdom

Facility Name

Local Institution

City

London

State/Province

Greater London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Local Institution

City

Southampton

State/Province

Hampshire

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Local Institution

City

Newcastle Upon Tyne

State/Province

Tyne And Wear

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27229685

Citation

Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.

Results Reference

derived

PubMed Identifier

24584926

Citation

Genovese MC, Tena CP, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Box J, Legerton CW 3rd, Nasonov E, Durez P, Delaet I, Teng J, Alten R. Subcutaneous abatacept for the treatment of rheumatoid arthritis: longterm data from the ACQUIRE trial. J Rheumatol. 2014 Apr;41(4):629-39. doi: 10.3899/jrheum.130112. Epub 2014 Mar 1.

Results Reference

derived

PubMed Identifier

21618201

Citation

Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Porawska W, Box J, Legerton C 3rd, Nasonov E, Durez P, Aranda R, Pappu R, Delaet I, Teng J, Alten R. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011 Oct;63(10):2854-64. doi: 10.1002/art.30463.

Results Reference

derived

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Methotrexate-Inadequate Response Study

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Methotrexate-Inadequate Response Study

Rheumatoid Arthritis (RA)

About this trial

Eligibility Criteria

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Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

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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

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