A Study to Assess the Efficacy and Safety of Retreatment With MabThera (Rituximab) in Patients With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Open-label Study of the Effect of MabThera Retreatment on Treatment Response in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093026
• Other study ID #: WA16855
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2014
• Last updated: April 2, 2016
• Start date: August 2002
• Est. completion date: October 2013

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into studies WA16291 or WA17043. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=21 years of age, with active RA;

• completed 24 weeks of treatment in WA16291 or WA17043;

• eligible for re-treatment, based on clinical symptoms;

• females of childbearing potential using reliable contraception.

Exclusion Criteria:

• patients who participated in MabThera studies WA16291 or WA17043 but withdrew into the safety follow-up phases of these trials;

• current treatment with any other disease-modifying drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;

• development of any new contraindications to receiving MabThera;

• female patients who are pregnant or breastfeeding.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• methylprednisolone
100 mg given IV at minimum 30 min before MabThera infusion on Days 1 and 15 of each treatment period
• rituximab [MabThera]
1 g given by intravenous (IV) infusion on Days 1 and 15 of each treatment period

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czech Republic,  Finland,  Germany,  Israel,  Italy,  Mexico,  New Zealand,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Proportion of patients with an ACR20 response achieved by retreatment\n\n		Approximately 5 years	No
Secondary	Proportion of patients reaching an ACR50 response		Approximately 5 years	No
Secondary	Proportion of patients reaching an ACR70 response		Approximately 5 years	No
Secondary	Proportion of patients with a EULAR response		Approximately 5 years	No
Secondary	Change in disease activity score (DAS28) from baseline		Approximately 5 years	No
Secondary	Change in American college of rheumatology score (ACR) from baseline		Approximately 5 years	No
Secondary	Change in total rheumatoid factors (RF) from baseline		Approximately 5 years	No
Secondary	Proportion of patients discontinuing treatment due to insufficient response		Approximately 5 years	No
Secondary	Time since last treatment course		Approximately 5 years	No
Secondary	Incidence of adverse events		Approximately 5 years	No