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A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis

NCT02693210 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2016-11-01

No results posted yet for this study

Summary

WA16291 is a Phase IIa "proof-of-concept" study. The primary objective of this study is to determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide in participants with rheumatoid arthritis who have failed prior Disease Modifying Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to methotrexate.

Conditions

Interventions

DRUG

Cyclophosphamide

Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17

DRUG

Methotrexate

Participants will receive \>= 10 mg/week methotrexate orally up to 24 weeks

OTHER

Placebo Cyclophosphamide

Participants will receive placebo in place of cyclophosphamide on Days 3 and 17

OTHER

Placebo Methotrexate

Participants will receive weekly oral placebo in place of Methotrexate

OTHER

Placebo Rituximab

Participants will receive placebo in place of rituximab on days 1 and 15

DRUG

Rituximab

Participants will receive 1g infusions of rituximab on Days 1 and 15

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hofffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2002-08-31
Completion
2004-08-31

Countries

  • Australia
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02693210 on ClinicalTrials.gov