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

NCT00124982 | Completed Phase 3 Results

• 1 other identifier: IM101-064
• Study Type: interventional
• Target: 1,286
• Locations: 10 countries
• Sites: 148

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (26)

• 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

  Days 1-169

• 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).

  Days 1-169

• 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.

  Days 1-169

• 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

  Days 1-169

• 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

  Days 1-169

• 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

  Days 1-169

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

  Day 1 (Baseline) -Day 169

• 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.

  Days 1-169

• 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

  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

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

• Long-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).

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

• 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.

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

• 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

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

• Long-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

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

• Long-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

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

• 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

  BL, Day 365, Day 729

• 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).

  BL, Day 365, Day 729

• 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

  BL, Day 365, Day 729

• 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

  BL, Day 365, Day 729

• 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

  BL, Day 365, Day 729

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

  BL, Day 365, Day 729

• 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.

  BL, Day 365, Day 729

• 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

  BL, Day 365, Day 729

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

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

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

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

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

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

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

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

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

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

Secondary Outcomes (30)

• 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

  BL, Day 169

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

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

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

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

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

  BL, Day 169

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

  BL, Day 169

Study Arms (3)

Open-label Abatacept (ABA)-Previous User

EXPERIMENTAL

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.

Drug: Abatacept; Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Open-label ABA-Current User

EXPERIMENTAL

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.

Drug: Abatacept; Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD); Drug: Anti-Tumor Necrosing Factor (TNF) Therapy

Long-term ABA

EXPERIMENTAL

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

Drug: Abatacept; Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Interventions

Abatacept DRUG

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

Also known as: Orencia

Long-term ABA; Open-label ABA-Current User; Open-label Abatacept (ABA)-Previous User

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

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).

Long-term ABA; Open-label ABA-Current User; Open-label Abatacept (ABA)-Previous User

Anti-Tumor Necrosing Factor (TNF) Therapy DRUG

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

Open-label ABA-Current User

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (148)

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Paradise Valley, Arizona, United States

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Peoria, Arizona, United States

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Tucson, Arizona, United States

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Long Beach, California, United States

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Palm Springs, California, United States

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Palo Alto, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Danbury, Connecticut, United States

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Hamden, Connecticut, United States

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Trumbull, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Aventura, Florida, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Jupiter, Florida, United States

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Largo, Florida, United States

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Sarasota, Florida, United States

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Atlanta, Georgia, United States

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Blue Ridge, Georgia, United States

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Macon, Georgia, United States

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Morton Grove, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Prairie Village, Kansas, United States

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Bowling Green, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Peabody, Massachusetts, United States

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Springfield, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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East Lansing, Michigan, United States

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Grand Rapids, Michigan, United States

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Lansing, Michigan, United States

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Petockey, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Paul, Minnesota, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Nashua, New Hampshire, United States

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Cherry Hill, New Jersey, United States

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Dover, New Jersey, United States

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Manalapan, New Jersey, United States

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New Brunswick, New Jersey, United States

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Somerset, New Jersey, United States

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Teaneck, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Hewlett, New York, United States

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Lake Success, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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Olean, New York, United States

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Orchard Park, New York, United States

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Rochester, New York, United States

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Schenectady, New York, United States

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Smithtown, New York, United States

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Syracuse, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Wilmington, North Carolina, United States

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Bismarck, North Dakota, United States

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Akron, Ohio, United States

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Beachwood, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Mayfield Village, Ohio, United States

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Youngstown, Ohio, United States

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Portland, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Meadville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Wexford, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Providence, Rhode Island, United States

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Myrtle Beach, South Carolina, United States

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Simpsonville, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Hixson, Tennessee, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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San Antonio, Texas, United States

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Sugarland, Texas, United States

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Burke, Virginia, United States

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Chesapeake, Virginia, United States

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Fairfax, Virginia, United States

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Salem, Virginia, United States

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Seattle, Washington, United States

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Vancouver, Washington, United States

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Glendale, Wisconsin, United States

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La Crosse, Wisconsin, United States

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Madison, Wisconsin, United States

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Brussels, Belgium

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Leuven, Belgium

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Prague, Czechia

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Boisguillaume, France

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Bordeaux, France

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Brest, France

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Chambray-lès-Tours, France

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Montpellier, France

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Nice, France

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Paris, France

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Rennes, France

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Strasbourg, France

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Toulouse, France

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Freiburg im Breisgau, Germany

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Hamburg, Germany

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Kiel, Germany

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Leipzig, Germany

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Tübingen, Germany

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Cork, Cork, Ireland

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Genova, Italy

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Milan, Italy

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Torino, Italy

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Guadalajara, Jalisco, Mexico

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Distrito Federal, Mexico City, Mexico

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Local Institution

Alicante, Spain

Location

Local Institution

Barcelona, Spain

Location

Local Institution

Guipuzcoa, Spain

Location

Local Institution

Madrid, Spain

Location

Local Institution

Santander, Spain

Location

Local Institution

Valencia, Spain

Location

Local Institution

Cambridge, Cambridgeshire, United Kingdom

Location

Local Institution

Manchester, Greater Manchester, United Kingdom

Location

Local Institution

Maidstone, Kent, United Kingdom

Location

Local Institution

Leeds, North Yorkshire, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 19074911 BACKGROUND

• 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.

  PMID: 29329602 DERIVED

• 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.

  PMID: 27889300 DERIVED

• 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.

  PMID: 18402714 DERIVED

• 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.

  PMID: 17921185 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept; Therapeutics

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 29, 2005
• Study Start: April 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 27, 2012
• Results First Posted: June 2, 2011

Record last verified: 2012-02

Locations

CZ (1); FR (10); GB (4); US (114); ES (6); DE (5); IE (1); BE (2); IT (3); ME (2)