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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 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.

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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.

Conditions Studied

Rheumatoid Arthritis

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

FieldValue
Enrollment Target 251 participants
Start Date 2015-03
Est. Completion 2016-07
Phase Phase 2

Sponsor

Ablynx, a Sanofi company

9 total trials

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What the Registry Record Tells You About NCT02287922

The ClinicalTrials.gov registry entry for NCT02287922 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 251 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (95% lower). The listed sponsor is Ablynx, a Sanofi company, which has 9 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.