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A Study to Evaluate Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis (SERENE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Genentech.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00299130
First received: March 3, 2006
Last updated: November 11, 2010
Last verified: November 2010
History of Changes
  Purpose

This study will evaluate the efficacy and safety of rituximab in patients with RA. Patients will be randomized to receive rituximab or placebo, and all patients will receive concomitant methotrexate, 10-25 mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: folate
Drug: methotrexate
Drug: methylprednisolone
Drug: placebo
Drug: rituximab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Proportion of patients with ACR20 response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with ACR50 and ACR70 response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in DAS28, ACR core set, SF36, and FACIT-F fatigue assessment from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • EULAR response rates [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: November 2005
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: folate
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: rituximab
Intravenous repeating dose
Experimental: 2 Drug: folate
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: rituximab
Intravenous repeating dose
Placebo Comparator: 3 Drug: folate
Intravenous repeating dose
Drug: methotrexate
Oral or parenteral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: placebo
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adult patients 18-80 years of age
  • RA for ≥ 6 months
  • Receiving outpatient treatment
  • Inadequate response to methotrexate, having received and tolerated it for ≥ 12 weeks

Exclusion criteria:

  • Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
  • Inflammatory joint disease other than RA, or other systemic autoimmune disorder
  • Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16
  • Surgery within 12 weeks of study
  • Previous treatment with any approved or investigational biologic agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299130

Sponsors and Collaborators
Genentech
Roche Pharma AG
Investigators
Study Director: Annie Chen, M.D. Genentech
  More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00299130     History of Changes
Other Study ID Numbers: U2973g, WA17045
Study First Received: March 3, 2006
Last Updated: November 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
RA
Rituxan
SERENE

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Rituximab
Methylprednisolone Hemisuccinate
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
 Prednisolone hemisuccinate
Prednisolone phosphate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on May 23, 2013