Trial · NCT00124982
Outcomes56
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 56
Download this page as JSON| 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 |
| SECONDARY | 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 | All treated participants. n=number of evaluable participants. | units on a scale | MEAN |
| SECONDARY | Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP) | BL, Day 169 | All treated participants | mg/dL | MEAN |
| SECONDARY | Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) | BL, Day 169 | All treated participants | IU/mL | MEAN |
| SECONDARY | Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI) | BL, Day 169 | All treated participants | units on a scale | MEAN |
| SECONDARY | Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response | BL, Day 169 | All treated participants | participants | NUMBER |
| SECONDARY | Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores | BL | All treated participants. n=number of evaluable participants. | units on a scale | MEAN |
| 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 | All treated participants | participants | NUMBER |
| 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 | All treated participants | participants | NUMBER |
| PRIMARY | Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria | From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept | Participants who received at least 1 infusion of abatacept during the long-term treatment period. n=number of participants with evaluable laboratory results. | participants | NUMBER |
| PRIMARY | Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria | From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept | All treated participants. n=number of participants with evaluable laboratory results. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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