Trial · NCT01364389
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 | Polymyalgia Rheumatica Activity Score (PMR-AS) | Baseline, Day 15 | The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient's elevation on upper limbs, patient's assessment of pain, and physician's global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants. |
| Secondary | Time to Partial Clinical Response | Day 15 | The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had: \>50% reduction in patient global assessment visual analogue scale (VAS) compared with baseline and morning stiffness \< 60 minutes. |
| Secondary | Time to Complete Clinical Response | Day 15 | The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: \>70% reduction in patient global assessment VAS compared with baseline, morning stiffness \< 30 min, CRP \< 1.0 mg/dL and/or ESR \< 30 mm/1st hr. |
| Secondary | Time to First Flare | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. Only 1 participant experienced a flare, in the AIN457 treatment group. The flare for this one participant occurred on study day 44 |
| Secondary | Number of Flares Over a 6 Month Period | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. |
| Secondary | Mean Steroid Dose Over a 6 Month Period | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. |
| Secondary | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | 6 months | |
| Secondary | Comparison Between the Initial Response to AIN457 and ACZ885 and the Response After Re-dosing of AIN457 and ACZ885 - Assessed by the Number of Flares After Redosing. | 6 months | One participant experienced one flare after initial dose but this participant had no flare after a redose. This patient was in the AIN457 arm. |
| Secondary | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | 6 months | The Short Form-36 (SF-36) Questionnaire is a 36-item questionnaire yields an 8-scale health profile as well as summary measures of individual patients.. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health. |
| Secondary | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) | baseline and at month 6 | HAQ: The scores range from 0 (min) to 3 (max). Higher scores = more disability; lower scores = less disability. |
| Secondary | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) - % Change From Baseline in the Standard Disability Score at EOS / Month 6 | 6 months | HAQ: The scores range from 0 (min) to 3 (max). Higher scores = more disability; lower scores = less disability. |
| Secondary | Pharmacokinetics of AIN457 and ACZ885 - Cmax | Day 15 | |
| Secondary | Pharmacokinetics of AIN457 and ACZ885 - Tmax | Day 15 | |
| Secondary | Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast | Day 15 | |
| Secondary | Pharmacokinetics of AIN457 and ACZ885 - CL | Day 15 | |
| Secondary | Pharmacokinetics of AIN457 and ACZ885 - Vz | Day 15 | |
| Secondary | Pharmacokinetics of AIN457 and ACZ885 - T1/2 | Day 15 |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01364389/registered