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NCT02309359 · ClinicalTrials.gov registry record · Phase 2
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
A Phase 2 study, sponsored by Ablynx, a Sanofi company.
- Completed
- Registry status
- Phase 2
- Development phase
- 345
- Enrollment target
NCT02309359 is a Phase 2 study that has completed, run by Ablynx, a Sanofi company. The registered enrollment target is 345 participants.
The verdict
NCT02309359, a Phase 2 study, has completed, sponsored by Ablynx, a Sanofi company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 345 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo. To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.
Interventions
- OTHER Placebo
- DRUG Methotrexate
- BIOLOGICAL ALX-0061
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02309359
The ClinicalTrials.gov registry entry for NCT02309359 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 345 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ablynx, a Sanofi company, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02309359 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02309359 about?
NCT02309359 is a clinical study titled "A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis". The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo. To assess the effects of ALX-0061 on qu...
What is the current status of trial NCT02309359?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 345 participants. The study started on 2015-01. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02309359?
The interventions under investigation include: Placebo (OTHER), Methotrexate (DRUG), ALX-0061 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02309359?
This trial is sponsored by Ablynx, a Sanofi company, which has 9 total clinical trials registered on ClinicalTrials.gov.
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