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NCT01109940 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT01109940 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 39 participants.
The verdict
NCT01109940, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of Intravenous infusion (IV) of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue dosing for another 6 month period (Part 2).
Interventions
- BIOLOGICAL AIN457A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01109940
The ClinicalTrials.gov registry entry for NCT01109940 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 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 1 intervention - of which AIN457A is the first listed.
NCT01109940 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01109940 about?
NCT01109940 is a clinical study titled "Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis". This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will addres...
What is the current status of trial NCT01109940?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2010-04. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01109940?
The interventions under investigation include: AIN457A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01109940?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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