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NCT01392326 · ClinicalTrials.gov registry record · Phase 3
Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
A Phase 3 study of Psoriatic Arthritis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 606
- Enrollment target
- 20
- Study locations
NCT01392326: Completed Phase 3 study of Psoriatic Arthritis, sponsored by Novartis Pharmaceuticals.
NCT01392326 is a Phase 3 study of Psoriatic Arthritis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 606 participants, below the 840-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01392326, a Phase 3 study of Psoriatic Arthritis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 606 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
Primary Outcome
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)
Conditions Studied
Interventions
- DRUG Placebo Comparator
- DRUG Secukinumab (75 mg)
- DRUG Secukinumab (150 mg)
Study Locations (20)
Arizona
- Novartis Investigative Site - Mesa
- Novartis Investigative Site - Paradise Valley
South Carolina
- Novartis Investigative Site - Columbia
- Novartis Investigative Site - North Charleston
Texas
- Novartis Investigative Site - Benbrook
- Novartis Investigative Site - Dallas
Alabama
- Novartis Investigative Site - Anniston
California
- Novartis Investigative Site - Upland
Florida
- Novartis Investigative Site - Tamarac
Georgia
- Novartis Investigative Site - Newnan
Massachusetts
- Novartis Investigative Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 606 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT01392326 record still lists
NCT01392326 is an interventional study that assigns participants to a tested intervention. The registered 606 participants enrollment target is mid-sized for trials with a published cap, below the 840-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (28% lower).
The record links to 1 condition, with Psoriatic Arthritis appearing as the primary indexed condition, and to 3 interventions - of which Placebo Comparator is the first listed.
NCT01392326 names 20 study sites across 17 states, led by Arizona, South Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT01392326 about?
NCT01392326 is a clinical study titled "Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)". This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
What is the current status of trial NCT01392326?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 606 participants. The study started on 2011-09. Estimated completion is 2014-10.
What conditions does trial NCT01392326 study?
This clinical trial studies the following conditions: Psoriatic Arthritis.
What interventions are being tested in trial NCT01392326?
The interventions under investigation include: Placebo Comparator (DRUG), Secukinumab (75 mg) (DRUG), Secukinumab (150 mg) (DRUG).
Who is sponsoring clinical trial NCT01392326?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01392326 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01392326's enrollment target sits among peer trials
606 13th of 48 higher than 36 of 48 other Psoriatic Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriatic Arthritis 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.
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