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 has been terminated.

( Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA. )

First Received on December 11, 2008. Last Updated on June 25, 2010 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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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: Prednisolone Prednisolone acetate Methylprednisolone acetate Methotrexate Methylprednisolone Prednisolone Sodium Phosphate Prednisolone phosphate Methylprednisolone Sodium Succinate Methotrexate sodium Infliximab Adalimumab

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
Experimental: A	Drug: methotrexate Oral or parenteral repeating dose Drug: methylprednisolone Intravenous repeating dose Drug: ocrelizumab Intravenous repeating dose Drug: sham Intravenous repeating dose
Active Comparator: B	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

Sponsors and Collaborators

Genentech

Investigators

Study Director:

William Reiss, Pharm.D.

Genentech

More Information

No publications provided

Responsible Party:	Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00808210 History of Changes
Other Study ID Numbers:	ACT4562g
Study First Received:	December 11, 2008
Last Updated:	June 25, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

RA
Arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Infliximab
TNFR-Fc fusion protein
Adalimumab
Methylprednisolone Hemisuccinate
Prednisolone
Methylprednisolone acetate

Prednisolone acetate
Methylprednisolone
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

ClinicalTrials.gov processed this record on May 23, 2012