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Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease

NCT02760407 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1648

Last updated 2023-09-21

Study results available
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Summary

The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving but not fully responding to treatment with methotrexate (MTX).

The primary objective of this study was to evaluate the efficacy of OKZ 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active RA inadequately controlled by MTX therapy.

The secondary objective was to evaluate the efficacy of OKZ relative to adalimumab in subjects with moderately to severely active RA inadequately controlled by MTX therapy.

Conditions

Interventions

DRUG

Olokizumab 64mg q4w

160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial

DRUG

Olokizumab 64mg q2w

160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial

DRUG

Adalimumab 40mg q2w

0.4 or 0.8 mL prefilled, single-dose syringe

DRUG

Placebo q2w

sodium chloride 0.9% solution supplied in either a 10 mL vial or ampoule, depending on market availability. Each placebo will be packed into a cardboard carton to contain 1 vial or ampoule

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • OCT Clinical Trials

    collaborator OTHER

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-06
Primary Completion
2019-08-02
Completion
2019-11-05
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Colombia
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • Mexico
  • Poland
  • Romania
  • Russia
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02760407 on ClinicalTrials.gov