Trial · NCT00413699
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports | Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug | For abnormal laboratory results, those listed include both mandatory and optional laboratory tests. The number of participants analyzed is the number with at least one evaluable observation of the given laboratory test. Fasting lipids were only collected from participants who enrolled more than 14 days after last visit of their qualifying study. | Number of participants | NUMBER |
| PRIMARY | Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) | Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months) | Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Extension Period: Number of Participants With Laboratory Test Abnormalities | Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months) | Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis | Includes AEs for every visit and up to 999 days after last dose of study drug | The stated number of participants analyzed is the total number of participants enrolled in each group. The number of evaluable participants is the number remaining in the study in the given time period. | Number of participants | NUMBER |
| PRIMARY | Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib | Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period | Safety analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants evaluable for specified categories. | Percentage of participants | NUMBER |
| SECONDARY | Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses | Every visit until study completion | The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point. | Percent of participants | NUMBER |
| SECONDARY | Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses | Month 3, 6, 9 and 12 of Extension Period | Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories. | Percentage of participants | NUMBER |
| SECONDARY | Initial Period: Area Under American College of Rheumatology (ACR) n Curve | Not applicable as no data were collected for this endpoint. | No data were collected for this endpoint as it was removed from the protocol in a protocol amendment. | ||
| SECONDARY | Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) | Every visit until study completion | The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point. | Score calculated from formula | MEAN |
| SECONDARY | Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 | Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period | Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories. | Scores on a scale | MEAN |
| SECONDARY | Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 | Every visit until study completion | Full Analysis Set - No Imputation. The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point. | Percent of participants | NUMBER |
| SECONDARY | Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 | Baseline (Day 1 at the entry of Extension period); Month 3, 6, 9 and 12 of Extension Period | Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories. | Percentage of participants | NUMBER |
| SECONDARY | Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Every visit until study completion | The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point. | Units on scale | MEAN |
| SECONDARY | Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12 | Baseline (Month 0 at the entry of Initial Period); Month 3, 6, 9, and 12 of Extension Period | Full analysis set included all participants who enrolled for extension period and received at least 1 dose of open label study medication in extension period. Here, Number Analyzed signifies number of participants who were evaluable for specified categories. | Units on a scale | MEAN |
| SECONDARY | Initial Period: Short-Form-36 Health Survey (SF-36) Score | Every visit until study completion | The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point. | Scores on scale | MEAN |
| SECONDARY | Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) | Every visit until study completion | The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point. | Scores on a scale | MEAN |
| SECONDARY | Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study | Every 6 months until study completion | The number of participants analyzed is the number remaining in the study who had evaluable data for the measure at the given time point. | Scores on a scale | MEAN |
| SECONDARY | Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by ≥ 2-fold Increase in Antibody Concentrations | From vaccine sub-study visit 2 (baseline) to sub-study visit 4 | Evaluable Immunogenicity Population | Percent of participants | NUMBER |
| SECONDARY | Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by ≥ 4-fold Increase in Antibody Titers | From vaccine sub-study visit 2 (baseline) to sub-study visit 4 | Evaluable Immunogenicity Population | Percent of participants | NUMBER |
| SECONDARY | Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of ≥ 1:40 in ≥ 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4 | From vaccine sub-study visit 2 (baseline) to sub-study visit 4 | Evaluable Immunogenicity Population | Percent of 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT00413699/outcomes