A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis

NCT01332994 | Completed Phase 3 Results

• 1 other identifier: ML22985
• Study Type: interventional
• Target: 519
• Locations: 1 country
• Sites: 83

Brief Summary

This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study treatment is 32 weeks.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Remission at Week 16 According to DAS28

  The DAS28 was calculated as \[0.28 times (x) the square root of number of swollen joints\] plus (+) \[0.56 x the square root of number of tender joints\] + \[0.7 x the natural log of erythrocyte sedimentation rate (ESR)\] + \[0.014 x Visual Analog Scale (VAS) patient global assessment of disease activity\]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score \<2.6 at the assessment visit.

  Week 16

Secondary Outcomes (52)

• Percentage of Participants Achieving Remission According to DAS28 at Weeks 4, 8, and 12

  Weeks 4, 8, and 12

• Percentage of Participants Achieving Remission According to DAS28 at Weeks 16, 20, 24, and 28 Among Participants Treated With 8 Courses of Tocilizumab

  Weeks 16, 20, 24, and 28

• Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Participants Treated With 8 Courses of Tocilizumab

  Week 32

• Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Nonresponding Participants Treated With Rituximab

  Week 32

• Percentage of Participants Achieving Low Disease Activity Score (LDAS) According to DAS28

  Week 16

Study Arms (2)

1

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

2

EXPERIMENTAL

Drug: rituximab [MabThera/Rituxan]; Drug: tocilizumab [RoActemra/Actemra]

Interventions

rituximab [MabThera/Rituxan] DRUG

1 g intravenously at Week 16 and 18

2

tocilizumab [RoActemra/Actemra] DRUG

8 mg/kg intravenously every 4 weeks for 12 weeks.

1; 2

Eligibility Criteria

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

You may qualify if:

• Adult patients \>/=18 years of age
• Body weight \< /=130kg
• Active rheumatoid arthritis of at least 6 months duration, diagnosed according to the American College of Rheumatology (ACR) criteria of 1987
• Disease Activity Score (DAS28) of \>3.2
• Inadequate clinical response to a stable dose of traditional Disease-Modifying Anti-Rheumatic Drugs (DMARD)
• Have received permitted DMARDs, one or more; current DMARD therapy must have been at stable dose for at least 4 weeks prior to baseline

You may not qualify if:

• Prior treatment with TNF-inhibitors or other biologic DMARD
• Major surgery (including joint surgery) within eight weeks prior to baseline or planned major surgery within the study duration
• Functional class IV (American College of Rheumatology classification)
• Rheumatic autoimmune disease other than rheumatoid arthritis
• History of or current inflammatory joint disease other than rheumatoid arthritis

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (83)

Unknown Facility

Aachen, 52064, Germany

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Bad Aibling, 83043, Germany

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Bad Bramstedt, 24576, Germany

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Bad Nauheim, 61231, Germany

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Bad Staffelstein, 96231, Germany

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Bayreuth, 95445, Germany

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Berlin, 10117, Germany

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Berlin, 10435, Germany

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Berlin, 12161, Germany

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Berlin, 12435, Germany

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Berlin, 13055, Germany

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Berlin, 13125, Germany

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Berlin, 14129, Germany

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Blaubeuren Abbey, 89143, Germany

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Bonn, 53111, Germany

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Bruchhausen-Vilsen, 27305, Germany

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Chemnitz, 09130, Germany

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Cologne, 50679, Germany

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Cologne, 50924, Germany

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Cologne, 51149, Germany

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Donaueschingen, 78166, Germany

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Dresden, 01067, Germany

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Dresden, 01097, Germany

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Dresden, 01109, Germany

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Dresden, 01307, Germany

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Düsseldorf, 40217, Germany

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Düsseldorf, 40225, Germany

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Erfurt, 99096, Germany

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Essen, 45239, Germany

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Frankfurt am Main, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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Giessen, 35392, Germany

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Gommern, 39245, Germany

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Goslar, 38642, Germany

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Göttingen, 37075, Germany

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Greifswald, 17475, Germany

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Halle, 06108, Germany

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Halle, 06120, Germany

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Halle, 06128, Germany

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Hamburg, 20246, Germany

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Hamburg, 22147, Germany

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Hamburg, 22767, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Heidelberg, 69121, Germany

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Herne, 44652, Germany

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Hildesheim, 31134, Germany

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Hofheim, 65719, Germany

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Jena, 07747, Germany

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Kiel, 24105, Germany

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Leipzig, 04103, Germany

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Leipzig, 04109, Germany

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Lingen, 49808, Germany

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Ludwigsfelde, 14974, Germany

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Mainz, 55131, 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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Naumburg, 06628, Germany

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Naunhof, 04683, Germany

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Neuss, 41460, Germany

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Neuss, 41462, Germany

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Nienburg, 31582, Germany

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Olsberg, 59939, Germany

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Osnabrück, 49074, Germany

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Plochingen, 73207, Germany

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Potsdam, 14469, Germany

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Ratingen, 40882, Germany

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Regensburg, 93053, Germany

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Rendsburg, 24768, Germany

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Rheine, 48431, Germany

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Rostock, 18059, Germany

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Saarbrücken, 66111, Germany

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Sendenhorst, 48324, Germany

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Stuttgart, 70178, Germany

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Stuttgart, 70372, Germany

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Traunstein, 83278, 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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Würzburg, 97080, Germany

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab; tocilizumab

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 DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: April 11, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: September 7, 2015
• Results First Posted: September 7, 2015

Record last verified: 2015-08

Locations

DE (83)