A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

NCT02079532 | Completed Phase 3 Results

• 1 other identifier: ML19070
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 69

Brief Summary

This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)

  The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-ated rheumatoid arthritis \[RA\] activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

  Week 24

Secondary Outcomes (18)

• DAS28 Score

  Screening and Weeks 8, 16, and 24

• Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate

  Weeks 8, 16, and 24

• Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24

  Week 24

• Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24

  Week 24

• Percentage of Participants Achieving a Response By EULAR Category

  Weeks 8, 16, and 24

Study Arms (1)

MabThera (Rituximab)

EXPERIMENTAL

Drug: rituximab [MabThera]

Interventions

rituximab [MabThera] DRUG

1 g was given by intravenous infusion on Days 1 and 15

MabThera (Rituximab)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, 18-75 years of age;
• rheumatoid arthritis for \>=6 months;
• previous inadequate response to a single anti-TNF alpha inhibitor;
• methotrexate at a stable dose range 7.5-25 mg/week.

You may not qualify if:

• other chronic inflammatory articular disease or systemic autoimmune disease;
• previous treatment with MabThera or intolerance to MabThera;
• corticosteroids\>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at unstable doses within last 2 weeks;

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (69)

Unknown Facility

Bad Abbach, 93077, Germany

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Bad Aibling, 83043, Germany

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Bad Bramstedt, 24576, Germany

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Bamberg, 96047, Germany

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Berlin, 10117, Germany

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Berlin, 12200, Germany

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Berlin, 13055, Germany

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Berlin, 13125, Germany

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Berlin, 13589, Germany

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Berlin, 14163, Germany

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Bonn, 53111, Germany

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Bremen, 28199, Germany

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Cologne, 50924, Germany

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Cuxhaven, 27476, Germany

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Damp, 24351, Germany

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Donaueschingen, 78166, Germany

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Dresden, 01109, Germany

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Düsseldorf, 40211, Germany

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Düsseldorf, 40225, Germany

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Erfurt, 99096, Germany

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Erlangen, 91054, Germany

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Erlangen, 91056, Germany

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Essen, 45239, Germany

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Essen, 45326, Germany

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Frankfurt am Main, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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Fulda, 36039, Germany

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Giessen, 35392, Germany

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Gommern, 39245, Germany

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Göttingen, 37075, Germany

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Hagen, 58135, Germany

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Halle, 06120, Germany

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Hamburg, 22081, Germany

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Hanover, 30159, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Herne, 44652, Germany

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Hofheim, 65719, Germany

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Homburg/saar, 66424, Germany

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Jena, 07743, Germany

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Karlsruhe, 76135, Germany

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Ludwigshafen, 67063, Germany

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Mainz, 55122, Germany

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Mainz, 55131, Germany

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Mittelherwigsdorf, 02763, Germany

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Mönchengladbach, 41061, Germany

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München, 80335, Germany

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München, 80336, Germany

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München, 81541, Germany

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Münster, 48149, Germany

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Naunhof, 04683, Germany

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Oldenburg, 26121, Germany

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Osnabrück, 49074, Germany

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Pirna, 01796, Germany

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Ratingen, 40882, Germany

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Rostock, 18059, Germany

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Schwerte, 58239, Germany

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Sendenhorst, 48324, Germany

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Stuttgart, 70178, Germany

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Treuenbrietzen, 14929, Germany

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Trier, 54292, Germany

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Tübingen, 72076, Germany

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Ulm, 89081, Germany

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Wiesbaden, 65189, Germany

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Wiesbaden, 65191, Germany

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Wuppertal, 42105, Germany

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Würselen, 52146, Germany

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Würzburg, 97080, Germany

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Zeven, 27404, Germany

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

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)

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-LaRoche

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 4, 2014
• First Posted: March 5, 2014
• Study Start: November 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 29, 2016
• Results First Posted: June 9, 2015

Record last verified: 2016-06

Locations

DE (69)