Trial · NCT00124982
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, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2011-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT00124982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00124982
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT00124982
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,286 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Rheumatoid Arthritis
- Interventions
- Abatacept, Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD), Anti-Tumor Necrosing Factor (TNF) Therapy
- First posted
- 2005-07-29
- Last updated
- 2012-02-27
- Results first posted
- 2011-06-02
Source ClinicalTrials.gov
Registered outcomes56
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Days 1-169 | 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 |
| Primary | Short-term Period: Number of Participants With AEs of Special Interest | Days 1-169 | 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). |
| Primary | Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria | Days 1-169 | 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. |
| Primary | Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria | Days 1-169 | 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 |
| Primary | Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria | Days 1-169 | 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 |
| Primary | Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria | Days 1-169 | 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 |
| Primary | Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure | Day 1 (Baseline) -Day 169 | |
| Primary | 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) | Days 1-169 | 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. |
| Primary | 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 | From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept | 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 |
| Primary | Long-term Period: Number of Participants With AEs of Special Interest | From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept | 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). |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 registered outcomesOutcomes56
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Days 1-169 | All treated participants | participants | NUMBER |
| PRIMARY | Short-term Period: Number of Participants With AEs of Special Interest | Days 1-169 | All treated participants | participants | NUMBER |
| SECONDARY | 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 | All treated participants. | participants | NUMBER |
| PRIMARY | Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria | Days 1-169 | Participants who received at least 1 infusion of abatacept during the short-term treatment period | participants | NUMBER |
| PRIMARY | Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria | Days 1-169 | All treated participants. n=number of participants with evaluable laboratory results. | participants | NUMBER |
| PRIMARY | Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria | Days 1-169 | All treated participants. n=number of participants with evaluable laboratory results. | participants | NUMBER |
| PRIMARY | Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria | Days 1-169 | All treated participants. n=number of participants with evaluable laboratory results. | participants | NUMBER |
| PRIMARY | Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure | Day 1 (Baseline) -Day 169 | Although mean values for systolic and diastolic blood pressure were recorded, mean changes from baseline were not summarized for these data. | mm Hg | MEAN |
| PRIMARY | 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) | Days 1-169 | Treated participants with available serum samples for assay | participants | NUMBER |
| SECONDARY | 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 | All treated participants. n=number of evaluable participants. | units on a scale | MEAN |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 outcomesResults by group952
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | ST Abatacept (ABA)-Previous User | Death | 1 | participants | |
| 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 | ST ABA-Current User | Death | 1 | participants | |
| 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 | ST Abatacept (ABA)-Previous User | SAEs | 50 | participants | |
| 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 | ST ABA-Current User | SAEs | 59 | participants | |
| 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 | ST Abatacept (ABA)-Previous User | Related SAEs | 10 | participants | |
| 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 | ST ABA-Current User | Related SAEs | 16 | participants | |
| 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 | ST Abatacept (ABA)-Previous User | SAEs Leading to Discontinuation | 9 | participants | |
| 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 | ST ABA-Current User | SAEs Leading to Discontinuation | 8 | participants | |
| 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 | ST Abatacept (ABA)-Previous User | AEs | 350 | participants | |
| 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 | ST ABA-Current User | AEs | 473 | participants |
1 to 10 of 952Source ClinicalTrials.gov
See all 952 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Short-term Period | STARTED | Short Term (ST) Abatacept (ABA)-Previous User | 449 | |
| Short-term Period | STARTED | ST-Current User | 597 | |
| Short-term Period | STARTED | Long-term ABA | 0 | |
| Short-term Period | COMPLETED | Short Term (ST) Abatacept (ABA)-Previous User | 377 | |
| Short-term Period | COMPLETED | ST-Current User | 483 | |
| Short-term Period | COMPLETED | Long-term ABA | 0 | |
| Short-term Period | NOT COMPLETED | Short Term (ST) Abatacept (ABA)-Previous User | 72 | |
| Short-term Period | NOT COMPLETED | ST-Current User | 114 | |
| Short-term Period | NOT COMPLETED | Long-term ABA | 0 | |
| Long-term Period | STARTED | Short Term (ST) Abatacept (ABA)-Previous User | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events324
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | HEADACHE | Nervous system disorders | Abatacept (LT) | 25 | 530 | |
| other | HEADACHE | Nervous system disorders | Abatacept (ST) | 102 | 1,046 | |
| other | NAUSEA | Gastrointestinal disorders | Abatacept (LT) | 26 | 530 | |
| other | NAUSEA | Gastrointestinal disorders | Abatacept (ST) | 90 | 1,046 | |
| other | DIARRHOEA | Gastrointestinal disorders | Abatacept (LT) | 24 | 530 | |
| other | DIARRHOEA | Gastrointestinal disorders | Abatacept (ST) | 58 | 1,046 | |
| other | SINUSITIS | Infections and infestations | Abatacept (LT) | 24 | 530 | |
| other | SINUSITIS | Infections and infestations | Abatacept (ST) | 63 | 1,046 | |
| other | BRONCHITIS | Infections and infestations | Abatacept (LT) | 30 | 530 | |
| other | BRONCHITIS | Infections and infestations | Abatacept (ST) | 49 | 1,046 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abatacept (LT) | ||
| Total, all-cause mortality | Abatacept (ST) | ||
| Total, other adverse events | Abatacept (LT) | 130 | 530 |
| Total, other adverse events | Abatacept (ST) | 372 | 1,046 |
| Total, serious adverse events | Abatacept (LT) | 61 | 530 |
| Total, serious adverse events | Abatacept (ST) | 110 | 1,046 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ST Abatacept (ABA)-Previous User vs ST ABA-Current User: Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response | Trial comparisons |
| Abatacept (LT) vs Abatacept (ST): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00124982
GET https://conductscience.org/api/trials/v1/NCT00124982/registered?page=2