Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02287922 · ClinicalTrials.gov registry record · Phase 2
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
A Phase 2 study of Rheumatoid Arthritis, sponsored by Ablynx, a Sanofi company.
- Completed
- Registry status
- Phase 2
- Development phase
- 251
- Enrollment target
- 20
- Study locations
NCT02287922: Completed Phase 2 study of Rheumatoid Arthritis, sponsored by Ablynx, a Sanofi company.
NCT02287922 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by Ablynx, a Sanofi company. The registered enrollment target is 251 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02287922, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by Ablynx, a Sanofi company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 251 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is: \- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA). The secondary objectives of this study are: * To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development. * To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.
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
Conditions Studied
Interventions
- BIOLOGICAL Tocilizumab
- BIOLOGICAL Placebo
- BIOLOGICAL ALX-0061
Study Locations (20)
California
- Investigator Site - Hemet
- Investigator Site - La Palma
- Investigator site - Los Angeles
- Investigator Site - Los Angeles
- Investigator site - Ventura
Florida
- Investigator site - Hialeah
- Investigator Site - Homestead
- Investigator Site - Orlando
Other
- Investigator Site - Brussels
- Investigator Site - Ghent
- Investigator Site - Liège
Alabama
- Investigator Site - Birmingham
Georgia
- Investigator Site - Stockbridge
Kansas
- Investigator site - Overland Park
Massachusetts
- Investigator Site - Worcester
New Mexico
- Investigator Site - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
What the finished NCT02287922 record still lists
NCT02287922 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 3 interventions - of which Tocilizumab is the first listed.
NCT02287922 names 20 study sites across 12 states, led by California, Florida, Other.
Frequently Asked Questions
What is clinical trial NCT02287922 about?
NCT02287922 is a clinical study titled "A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis". The primary objective of this study is: \- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA). The secondary objectives of this study are: * To assess the effects of ALX-0061 on quality of...
What is the current status of trial NCT02287922?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 251 participants. The study started on 2015-03. Estimated completion is 2016-07.
What conditions does trial NCT02287922 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT02287922?
The interventions under investigation include: Tocilizumab (BIOLOGICAL), Placebo (BIOLOGICAL), ALX-0061 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02287922?
This trial is sponsored by Ablynx, a Sanofi company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02287922 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rheumatoid Arthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02287922's enrollment target sits among peer trials
251 74th of 197 higher than 124 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of SPY072 in Rheumatic Disease
RECRUITING · Phase 2
-
Dynamic Treatment Regiments for Glucocorticoid Tapering
RECRUITING · Phase 2
-
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
RECRUITING · Phase 2
-
A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
RECRUITING · Phase 2
-
A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)
RECRUITING · Phase 2
-
An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
RECRUITING · Phase 2
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
- NCT06043817 · 251 participants · Phase 1
First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations
- NCT02314988 · 252 participants · Phase 2
Tranexamic Acid to Reduce Blood Loss in Spine Surgery
- NCT03941756 · 252 participants · NA
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
- NCT05219617 · 252 participants · Phase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
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