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NCT01364389 · ClinicalTrials.gov registry record · Phase 2
A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01364389 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 16 participants.
The verdict
NCT01364389, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare. It is a multicentric, multinational study. The protocol will seek to enroll a total of 30 patients, who will be randomized to the 3 arms at a ratio of 1:1:1. Patients will have a maximum screening period of 7 days with randomization at D1 for a dosing period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days) after their last biologic dose, whichever is greater, and followed by unblinded re-dosing in the case of a disease flare.
Interventions
- DRUG Placebo
- DRUG Prednisone
- DRUG AIN457
- DRUG ACZ885
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-02-14 |
| Est. Completion | 2013-01-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01364389
The ClinicalTrials.gov registry entry for NCT01364389 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01364389 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01364389 about?
NCT01364389 is a clinical study titled "A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica". The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare. It is a multicentric, multinationa...
What is the current status of trial NCT01364389?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2011-02-14. Estimated completion is 2013-01-29.
What interventions are being tested in trial NCT01364389?
The interventions under investigation include: Placebo (DRUG), Prednisone (DRUG), AIN457 (DRUG), ACZ885 (DRUG).
Who is sponsoring clinical trial NCT01364389?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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