A Study to Evaluate Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis - Full Text View

Sponsors and Collaborators:	Genentech Hoffmann-La Roche
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00299130

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 III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Folic acid Methylprednisolone Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
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

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
1: Experimental	Drug: folate Intravenous repeating dose Drug: methotrexate Oral or parenteral repeating dose Drug: methylprednisolone Intravenous repeating dose Drug: rituximab Intravenous repeating dose
2: Experimental	Drug: folate Intravenous repeating dose Drug: methotrexate Oral or parenteral repeating dose Drug: methylprednisolone Intravenous repeating dose Drug: rituximab Intravenous repeating dose
3: Placebo Comparator	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

Hoffmann-La Roche

Investigators

Study Director:

Annie Chen, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	U2973g, WA17045
Study First Received:	March 3, 2006
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00299130 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

RA
Rituxan
SERENE

Study placed in the following topic categories:

Antimetabolites
Anti-Inflammatory Agents
Immunologic Factors
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Arthritis, Rheumatoid
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate

Methylprednisolone Hemisuccinate
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Rituximab
Joint Diseases
Methylprednisolone acetate
Rheumatic Diseases
Folic Acid Antagonists
Immunosuppressive Agents
Glucocorticoids
Folic Acid
Prednisolone
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Arthritis, Rheumatoid
Antiemetics
Prednisolone acetate
Reproductive Control Agents
Hormones
Neuroprotective Agents

Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Methylprednisolone Hemisuccinate
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Joint Diseases
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 06, 2009