A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis
Trial · NCT01050998
Outcomes65
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 65
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 | Day 85 | The intent-to-treat (ITT) population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region | Day 85 | The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 | Day 85 | The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region | Day 85 | The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Day 85 | The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Day 85 | The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 | Day 85 | The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region | Day 85 | The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline up to Day 169 (follow-up) | The safety population included all participants who received any dose of investigational product. | participants | NUMBER |
| PRIMARY | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Day 169 (follow-up) | The safety population included all participants who received any dose of investigational product. | participants | NUMBER |
| PRIMARY | Number of Participants With Abnormal Electrocardiogram (ECG) Results | Baseline up to Day 169 (follow-up) | The safety population included all participants who received any dose of investigational product. | participants | NUMBER |
| PRIMARY | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Day 85 | The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | liters | MEAN |
| PRIMARY | Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region | Day 85 | The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively. | liters | MEAN |
| PRIMARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 | Baseline and Day 85 | The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively. | liters | MEAN |
| PRIMARY | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Day 85 | The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | percent diffusion capacity | MEAN |
| PRIMARY | Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region | Day 85 | The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively. | percent diffusion capacity | MEAN |
| PRIMARY | Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 | Baseline and Day 85 | The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively. | percent diffusion capacity | MEAN |
| PRIMARY | Dyspnea Score at Day 85 | Day 85 | The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Dyspnea Score at Day 85 | Baseline and Day 85 | The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively. | units on a scale | MEAN |
| PRIMARY | Categorized Dyspnea Score at Day 85 | Day 85 | The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | 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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