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Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis

NCT01682512 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2018-01-30

Study results available
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Summary

The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

BI 695500

DRUG

BI 695500

DRUG

Rituxan®

DRUG

Rituxan®

DRUG

MabThera®

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-05
Primary Completion
2015-11-17
Completion
2016-10-12

Countries

  • United States
  • Argentina
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01682512 on ClinicalTrials.gov