Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Ablynx, a Sanofi company.
NCT02309359 is a Phase 2 study that has completed, run by Ablynx, a Sanofi company. The registered enrollment target is 345 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (159% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ACR 20 response is defined as: * 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND * 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND * 20% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - visual analogue scale \[VAS\]) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical func
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 |
What the finished NCT02309359 record still lists
NCT02309359 is an interventional study that assigns participants to a tested intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (159% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02309359 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02309359's enrollment target sits among peer trials
345 136th of 2000 higher than 1,865 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03972657 · 345 participants · Phase 1
A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors
- NCT05107674 · 345 participants · Phase 1
A Study of NX-1607 in Adults With Advanced Malignancies
- NCT05700279 · 345 participants · NA
Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset
- NCT05781100 · 345 participants · NA
Investigating Baby Behavior and Family Technology Use Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia