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

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 (CINEMA)

This study is currently recruiting participants.

Verified by Genentech, October 2009

First Received: December 11, 2008 Last Updated: October 2, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Methylprednisolone Infliximab Etanercept Adalimumab Ocrelizumab

U.S. FDA Resources

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 Intravenous repeating dose Drug: ocrelizumab Intravenous repeating dose Drug: sham Intravenous repeating dose
B: Active Comparator	Drug: infliximab Intravenous repeating dose Drug: methotrexate Oral or parenteral repeating dose Drug: methylprednisolone Intravenous repeating dose Drug: sham Intravenous 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 118 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

William Reiss, Pharm.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	ACT4562g
Study First Received:	December 11, 2008
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00808210 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

RA
Arthritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Physiological Effects of Drugs
Arthritis, Rheumatoid
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
TNFR-Fc fusion protein
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

Methylprednisolone Hemisuccinate
Immune System Diseases
Antineoplastic Agents, Hormonal
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Antimetabolites
Immunologic Factors
Infliximab
Antineoplastic Agents
Prednisolone acetate
Reproductive Control Agents
Adalimumab
Neuroprotective Agents
Musculoskeletal Diseases
Sensory System Agents

ClinicalTrials.gov processed this record on February 08, 2010