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A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis

NCT01332994 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 519

Last updated 2015-09-07

Study results available
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Summary

This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study treatment is 32 weeks.

Conditions

Interventions

DRUG

rituximab [MabThera/Rituxan]

1 g intravenously at Week 16 and 18

DRUG

tocilizumab [RoActemra/Actemra]

8 mg/kg intravenously every 4 weeks for 12 weeks.

DRUG

tocilizumab [RoActemra/Actemra]

8 mg/kg intravenously every 4 weeks from Week 16 to Week 28

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT01332994 on ClinicalTrials.gov