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NCT01892436 · ClinicalTrials.gov registry record · Phase 3
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 460
- Enrollment target
NCT01892436: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01892436 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 460 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01892436, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 460 participants
- Enrollment target
Study Summary
This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.
Primary Outcome
Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: * Patient's assessment of Psoriatic Arthritis (PsA) pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Subject self-assessed disability (Health-Assessment Que
Interventions
- DRUG Placebo
- DRUG Secukinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2018-01-11 |
| Phase | Phase 3 |
What the finished NCT01892436 record still lists
NCT01892436 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01892436 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01892436 about?
NCT01892436 is a clinical study titled "Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis". This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability informa...
What is the current status of trial NCT01892436?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 460 participants. The study started on 2013-09-30. Estimated completion is 2018-01-11.
What interventions are being tested in trial NCT01892436?
The interventions under investigation include: Placebo (DRUG), Secukinumab (DRUG).
Who is sponsoring clinical trial NCT01892436?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01892436's enrollment target sits among peer trials
460 823rd of 2000 higher than 1,174 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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