A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT) - Full Text View

Sponsors and Collaborators:	Genentech Hoffmann-La Roche
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00476996

Purpose

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: leflunomide Drug: methotrexate Drug: ocrelizumab Drug: placebo	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Leflunomide Ocrelizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy

Further study details as provided by Genentech:

Primary Outcome Measures:

Percentage of patients with ACR20 responses [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with a major clinical response [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Proportion of patients achieving Disease Activity Score (DAS28) remission [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
Change in DAS28 from baseline [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
EULAR response rates [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
Proportion of patients achieving an ACR50 response [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
Proportion of patients achieving an ACR70 response [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
Proportion of patients with a reduction in the HAQ-DI score [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	May 2007
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: leflunomide Oral repeating dose Drug: methotrexate Oral or parenteral repeating dose Drug: ocrelizumab Intravenous repeating dose (200mg)
2: Experimental	Drug: leflunomide Oral repeating dose Drug: methotrexate Oral or parenteral repeating dose Drug: ocrelizumab Intravenous repeating dose (500mg)
3: Placebo Comparator	Drug: leflunomide Oral repeating dose Drug: methotrexate Oral or parenteral repeating dose Drug: placebo Intravenous repeating dose

Eligibility

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

Criteria

Inclusion Criteria:

Adult patients, ≥ 18 years of age
Rheumatoid arthritis for ≥ 3 months
Inadequate response to previous or current treatment with at least one anti-TNF-alpha agent
Receiving either leflunomide or methotrexate for ≥ 12 weeks, with a stable dose for the last 4 weeks

Exclusion Criteria:

Rheumatic autoimmune disease or inflammatory joint disease, other than RA
Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline

This study is no longer open for enrollment in the United States; enrollment is still open at sites outside of the United States. For Ex-U.S. site information, please follow the link under More Information to the Hoffmann-La Roche clinical trial registry website.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476996

Contacts

Contact: Genentech Trial Information Support Line

888-662-6728

Locations

United States, California
Genentech Trial Information Support Line	Recruiting
South San Franciso, California, United States, 94080

Sponsors and Collaborators

Genentech

Hoffmann-La Roche

Investigators

Study Director:

Wolfgang Dummer, M.D.

Genentech

More Information

Ex-U.S. Study Information (Ex-US this trial is sponsored/managed by Hoffmann-La Roche) This link exits the ClinicalTrials.gov site

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	ACT3986g, WA20495
Study First Received:	May 18, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00476996
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

RA
SCRIPT
anti-CD20
CD20

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Leflunomide
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009