A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab - Full Text View

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00808210

Purpose

This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: infliximab Drug: methotrexate Drug: methylprednisolone Drug: ocrelizumab Drug: sham	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Methylprednisolone Adalimumab Etanercept Infliximab Ocrelizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Official Title:	A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

Further study details as provided by Genentech:

Primary Outcome Measures:

Difference between treatment groups in the mean change from baseline in DAS28(ESR) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with clinical response of 20%, 50%, and 70% according to ACR criteria (i.e., ACR20, ACR50, and ACR70) [ Time Frame: Length of study ] [ Designated as safety issue: No ]
European League Against Rheumatism (EULAR) response rates [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) score [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	1
Study Start Date:	December 2008
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: methotrexate Oral or parenteral repeating dose Drug: methylprednisolone Intravenouse repeating dose Drug: ocrelizumab Intravenous repeating dose Drug: sham Intravenouse repeating dose
B: Active Comparator	Drug: infliximab Intravenouse repeating dose Drug: methotrexate Oral or parenteral repeating dose Drug: methylprednisolone Intravenouse repeating dose Drug: sham Intravenouse repeating dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 18 years
Current treatment for RA on an outpatient basis
Active disease
Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week.
Considered by Investigator to be a primary non-responder to their first anti-TNFα treatment for efficacy reasons

Exclusion Criteria:

Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)
Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab
Treatment with more than one prior anti-TNFα therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808210

Contacts

Contact: Genentech Trial Information Support Line

888-662-6728

Show 21 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

William Reiss, Pharm.D.

Genentech

More Information

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	ACT4562g
Study First Received:	December 11, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00808210
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

RA
Arthritis

Study placed in the following topic categories:

Autoimmune Diseases
Infliximab
Methylprednisolone
Joint Diseases
Arthritis, Rheumatoid
Methylprednisolone acetate
Prednisolone acetate
Rheumatic Diseases

Adalimumab
Folic Acid
Musculoskeletal Diseases
Arthritis
Prednisolone
Connective Tissue Diseases
Methotrexate
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Hormones
Neuroprotective Agents
Therapeutic Uses
Abortifacient Agents
Dermatologic Agents

Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Glucocorticoids
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009