A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

NCT02097745 | Completed Phase 3 Results

• 1 other identifier: WA17531
• Study Type: interventional
• Target: 341
• Locations: 11 countries
• Sites: 97

Brief Summary

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response

  A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity \[symptom-free and no arthritis symptoms\], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). The ACR20 response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.

  Baseline to the end of the retreatment period (up to 7 years, 6 months)

Secondary Outcomes (12)

• Change From Baseline in the Disease Activity Score 28 (DAS28)

  Baseline to the end of the retreatment period (up to 7 years, 6 months)

• Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission

  Baseline to the end of the retreatment period (up to 7 years, 6 months)

• Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses

  Baseline to the end of the retreatment period (up to 7 years, 6 months)

• Change From Baseline in the American College of Rheumatology n (ACRn) Response

  Baseline to the end of the retreatment period (up to 7 years, 6 months)

• Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

  Baseline to the end of the retreatment period (up to 7 years, 6 months)

Study Arms (1)

MabThera/Rituxan

EXPERIMENTAL

Drug: methotrexate; Drug: rituximab [MabThera/Rituxan]

Interventions

methotrexate DRUG

a 10-25 mg stable dose given orally or parenterally throughout study

MabThera/Rituxan

rituximab [MabThera/Rituxan] DRUG

1 g given by intravenous infusion on Days 1 and 15 of each treatment course

Also known as: MabThera/Rituxan

MabThera/Rituxan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients 18-80 years of age with active RA;
• patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
• eligible for re-treatment, based on clinical symptoms;
• patients of reproductive potential must be using reliable contraceptive methods.

You may not qualify if:

• patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
• current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
• development of any new contraindications to receiving MabThera;
• women who are pregnant or breast-feeding.

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Biogen: collaborator

Study Sites (97)

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Mesa, Arizona, 85208, United States

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Paradise Valley, Arizona, 85253, United States

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Tucson, Arizona, 85724, United States

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Little Rock, Arkansas, 72205, United States

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Fullerton, California, 92835, United States

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Los Angeles, California, 90045, United States

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Los Angeles, California, 90048, United States

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Pasadena, California, 91105, United States

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Rancho Mirage, California, 92270, United States

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Santa Maria, California, 93454, United States

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Danbury, Connecticut, 06810, United States

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Boca Raton, Florida, 33486, United States

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Delray Beach, Florida, 33484, United States

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Fort Lauderdale, Florida, 33334, United States

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Jupiter, Florida, 33458, United States

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Orlando, Florida, 32806, United States

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Boise, Idaho, 83702, United States

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Coeur d'Alene, Idaho, 83814, United States

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Meridian, Idaho, 83642, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60637, United States

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Indianapolis, Indiana, 46202-5149, United States

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Indianapolis, Indiana, 46260, United States

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Shreverport, Louisiana, 71103, United States

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Baltimore, Maryland, 21224, United States

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Boston, Massachusetts, 02215, United States

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Kalamazoo, Michigan, 49048, United States

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Lansing, Michigan, 48910, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63141, United States

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Albany, New York, 12206, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10003, United States

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Rochester, New York, 14618, United States

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Smithtown, New York, 11787, United States

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Chapel Hill, North Carolina, 27599-7600, United States

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Greenville, North Carolina, 27834, United States

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Cincinnati, Ohio, 45267-0563, United States

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Dayton, Ohio, 45402, United States

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Mayfield, Ohio, 44143, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73109, United States

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Tulsa, Oklahoma, 74135, United States

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Duncansville, Pennsylvania, 16635, United States

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Philadelphia, Pennsylvania, 19140, United States

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Philadelphia, Pennsylvania, 19141, United States

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Philadelphia, Pennsylvania, 19152, United States

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Amarillo, Texas, 79124, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77074, United States

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Waco, Texas, 76710, United States

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Salt Lake City, Utah, 84132, United States

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Burlington, Vermont, 05401, United States

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Seattle, Washington, 98101, United States

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Seattle, Washington, 98104, United States

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Spokane, Washington, 99204, United States

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Madison, Wisconsin, 53792, United States

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Brussels, 1070, Belgium

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Calgary, Alberta, T2N 4Z6, Canada

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Edmonton, Alberta, T6G 2S2, Canada

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Hamilton, Ontario, L8N 2B6, Canada

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London, Ontario, N6A 4V2, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Bois-Guillaume, 76233, France

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Le Kremlin-Bicêtre, 94275, France

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Montpellier, 34295, France

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Paris, 75679, France

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Toulouse, 31059, France

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Berlin, 10117, Germany

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Dresden, 01067, Germany

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Leipzig, 04103, Germany

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Ratingen, 40882, Germany

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Würzburg, 97080, Germany

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Cork, Ireland

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Dublin, 4, Ireland

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Haifa, 3109601, Israel

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Haifa, 3339419, Israel

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Jerusalem, 9112001, Israel

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Petah Tikva, 4941492, Israel

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Ramat Gan, 5262000, Israel

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Tel Aviv, 6423906, Israel

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Udine, Friuli Venezia Giulia, 33100, Italy

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Brescia, Lombardy, 25123, Italy

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Pisa, Tuscany, 56100, Italy

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Amsterdam, 1105 AZ, Netherlands

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Drammen, 3004, Norway

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Oslo, 0370, Norway

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Tromsø, 9038, Norway

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Cannock, WS11 5XY, United Kingdom

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Leeds, LS7 4SA, United Kingdom

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London, E11 1NR, United Kingdom

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Manchester, M41 5SL, United Kingdom

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Newcastle upon Tyne, NE1 4LP, United Kingdom

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Related Publications (1)

• Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908. doi: 10.1002/art.23059.

  PMID: 18050221 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; Rituximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 27, 2014
• Study Start: June 1, 2004
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 3, 2016
• Results First Posted: November 7, 2014

Record last verified: 2016-09

Locations

FR (5); NL (1); IE (2); DE (5); IT (3); US (59); NO (3); IL (6); BE (3); CA (5); GB (5)