Trial · NCT00559585
Methotrexate-Inadequate Response Study
NCT00559585, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2011-07-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Methotrexate-Inadequate Response Study. Trials, record NCT00559585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00559585
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methotrexate-Inadequate Response Study
- NCT number
- NCT00559585
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,492 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Rheumatoid Arthritis (RA)
- Interventions
- Subcutaneous (SC) Abatacept, Intravenous (IV) Abatacept
- First posted
- 2007-11-16
- Last updated
- 2015-11-09
- Other registries' IDs
- eudract:2007-005434-37
- Results first posted
- 2011-07-06
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 | 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). |
| Primary | 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 | Days 85, and 169 and postvisits on Days 28, 56, and 85 | 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 | Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169 | 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. |
| Secondary | Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169 | 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. |
| Secondary | Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI | Baseline to Day 169 | 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. |
| Secondary | Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169 | 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. |
| Secondary | 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 | Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first. | 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 |
| Secondary | Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died | Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first. | 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. |
| Secondary | Double-blind Period: Number of Participants With AEs of Special Interest | Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first. | 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 |
| Secondary | Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements | Day 1 through end of short-term period (Day 169) | 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. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 | Day 169 | Per protocol (PP) population, defined as participants who are compliant with the study criteria. | participants | NUMBER |
| SECONDARY | Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169 | Day 169 | PP population, defined as participants who are compliant with the study criteria. | participants | NUMBER |
| SECONDARY | Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169 | Day 169 | All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available. | units on a scale | MEAN |
| SECONDARY | Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI | Baseline to Day 169 | All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available. | units on a scale | MEAN |
| SECONDARY | Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169 | Day 169 | All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available | participants | NUMBER |
| SECONDARY | 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 | Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first. | All randomized participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died | Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first. | All randomized participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Double-blind Period: Number of Participants With AEs of Special Interest | Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first. | All randomized participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements | Day 1 through end of short-term period (Day 169) | All randomized participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality | Day 1 through end of short-term period (Day 169) | All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available. | participants | NUMBER |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group334
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 | Subcutaneous Abatacept | 527 | participants | ||
| Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 | Intravenous Abatacept | 514 | participants | ||
| Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169 | Subcutaneous Abatacept | ACR 50 | 357 | participants | |
| Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169 | Intravenous Abatacept | ACR 50 | 341 | participants | |
| Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169 | Subcutaneous Abatacept | ACR 70 | 183 | participants | |
| Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169 | Intravenous Abatacept | ACR 70 | 170 | participants | |
| Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169 | Subcutaneous Abatacept | 1.72 | Standard Deviation 0.68 | units on a scale | |
| Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169 | Intravenous Abatacept | 1.67 | Standard Deviation 0.67 | units on a scale | |
| Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI | Subcutaneous Abatacept | -0.69 | Standard Error 0.02 | units on a scale | |
| Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI | Intravenous Abatacept | -0.70 | Standard Error 0.02 | units on a scale |
1 to 10 of 334Source ClinicalTrials.gov
See all 334 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind ST Period Main Study | STARTED | Subcutaneous (SC) Abatacept | 736 | |
| Double Blind ST Period Main Study | STARTED | Intravenous (IV) Abatacept | 721 | |
| Double Blind ST Period Main Study | COMPLETED | Subcutaneous (SC) Abatacept | 693 | |
| Double Blind ST Period Main Study | COMPLETED | Intravenous (IV) Abatacept | 676 | |
| Double Blind ST Period Main Study | NOT COMPLETED | Subcutaneous (SC) Abatacept | 43 | |
| Double Blind ST Period Main Study | NOT COMPLETED | Intravenous (IV) Abatacept | 45 | |
| Anti-TNF Sub-Study in ST Period | STARTED | Subcutaneous (SC) Abatacept | 8 | |
| Anti-TNF Sub-Study in ST Period | STARTED | Intravenous (IV) Abatacept | 10 | |
| Anti-TNF Sub-Study in ST Period | COMPLETED | Subcutaneous (SC) Abatacept | 7 | |
| Anti-TNF Sub-Study in ST Period | COMPLETED | Intravenous (IV) Abatacept | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events734
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 | Abdominal pain | Gastrointestinal disorders | IV Abatacept | 27 | 731 | |
| other | Abdominal pain | Gastrointestinal disorders | SC Abatacept | 39 | 744 | |
| other | Depression | Psychiatric disorders | IV Abatacept | 40 | 731 | |
| other | Depression | Psychiatric disorders | SC Abatacept | 37 | 744 | |
| other | Dizziness | Nervous system disorders | IV Abatacept | 40 | 731 | |
| other | Dizziness | Nervous system disorders | SC Abatacept | 37 | 744 | |
| other | Abdominal pain upper | Gastrointestinal disorders | IV Abatacept | 47 | 731 | |
| other | Abdominal pain upper | Gastrointestinal disorders | SC Abatacept | 43 | 744 | |
| other | Hypertension | Vascular disorders | IV Abatacept | 85 | 731 | |
| other | Hypertension | Vascular disorders | SC Abatacept | 96 | 744 |
1 to 10 of 734Source ClinicalTrials.gov
See all 734 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IV Abatacept | ||
| Total, all-cause mortality | SC Abatacept | ||
| Total, other adverse events | IV Abatacept | 544 | 731 |
| Total, other adverse events | SC Abatacept | 567 | 744 |
| Total, serious adverse events | IV Abatacept | 206 | 731 |
| Total, serious adverse events | SC Abatacept | 199 | 744 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Subcutaneous Abatacept vs Intravenous Abatacept: Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 | Trial comparisons |
| Subcutaneous Abatacept vs Intravenous Abatacept: Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements | Trial comparisons |
| Subcutaneous Abatacept vs Intravenous Abatacept: Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169 | Trial comparisons |
| IV Abatacept vs SC Abatacept: 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/NCT00559585
GET https://conductscience.org/api/trials/v1/NCT00559585/registered?page=2