Trial · NCT00559585
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| 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. |
| 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) | 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. |
| Secondary | Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality | Day 1 through end of short-term period (Day 169) | 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 |
| Secondary | Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality | Day 1 through end of short-term period (Day 169) | 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 |
| Secondary | Double-blind Period: Minimum Observed Serum Concentration of Abatacept | Days 57, 85, 113, 120, 127, 134, 141, and 169 | |
| Secondary | Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept | Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period) | 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. |
| Secondary | Double-blind Period: Maximum Observed Serum Concentration of Abatacept | End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous | |
| Secondary | Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept | End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous | 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). |
| Secondary | Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept | Dosing interval between Days 113 and 141 (TAU=28 days) | |
| Secondary | Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept | Dosing Interval between Days 113 and 141 (TAU=28 days) | 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. |
| Secondary | 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) | Days 85, and 169 and postvisits on Days 28, 56, and 85 | 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). |
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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