Trial · NCT01679951
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Activity Score 28 (DAS28) (C-reactive protein [CRP]) at Week 12 | Baseline and Week 12 | The DAS28 using CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and Patient's Global Assessment of Disease Activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. |
| Secondary | Change from baseline in DAS28 (CRP) at Week 24 | Baseline and Week 24 | |
| Secondary | Change from baseline in DAS28 (erythrocyte sedimentation rate [ESR]) at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | |
| Secondary | DAS28 (CRP) response rates at Week 12 and Week 24 | Week 12 and Week 24 | |
| Secondary | DAS28 (ESR) response rates at Week 12 and Week 24 | Week 12 and Week 24 | |
| Secondary | DAS28 (CRP) remission rates at Week 12 and Week 24 | Week 12 and Week 24 | |
| Secondary | DAS28 (ESR) remission rates at Week 12 and Week 24 | Week 12 and Week 24 | |
| Secondary | American College of Rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24 | Week 12 and Week 24 | An ACR 20/50/70 response is defined as a greater than or equal to 20/50/70 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP). |
| Secondary | Hybrid ACR response at Week 12 and Week 24 | Week 12 and Week 24 | The hybrid ACR response is a continuous variable that is limited to an overall score of -100 (maximal worsening) to +100 (maximal improvement). |
| Secondary | ACR/European League Against Rheumatism (EULAR) remission rates at Week 12 and Week 24 | Week 12 and Week 24 | According to the ACR/EULAR provisional definition, a patients RA can be defined as being in remission based on either of 2 definitions: when scores on the tender joint count, swollen joint count, CRP (in mg/dL), and patient global assessment (0-10 scale) are all less than or equal to 1 OR when the score on the simplified disease activity index (SDAI) is less than or equal to 3.3 Analyses based on each definition will be performed. |
| Secondary | Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | The SDAI is the numerical sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment of disease activity (PGA VAS in cm), physician global assessment of disease activity (MDGA VAS in cm) and C-reactive protein (CRP in mg/dL). |
| Secondary | Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | The CDAI is the numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA, and MDGA. |
| Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) response at Week 12 and Week 24 | Week 12 and Week 24 | The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). |
| Secondary | Change from baseline in HAQ-DI score at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | |
| Secondary | Percent change from baseline in ESR levels at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | |
| Secondary | Percent change from baseline in ACR components at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | |
| Secondary | Number of patients with adverse events | Up to Week 28 |
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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