A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy

NCT ID: NCT02001987

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

Brief Summary

This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of tocilizumab as a monotherapy or in combination with methotrexate or other conventional synthetic disease modifying antirheumatic drugs (csDMARDs) in participants with moderate to severe active rheumatoid arthritis who have an inadequate response or are intolerant to non-biologic csDMARDs and/or biologic therapy.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab

Participants will receive tocilizumab at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week administered as monotherapy or in combination with methotrexate or other csDMARDs (at investigator's discretion) for 24 weeks. Participants who complete the core study period will be allowed to enter a long-term-extension (LTE) period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC tocilizumab, whichever occurs first.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

Tocilizumab will be administered at a dose of 162 mg as SC injection once a week.

Methotrexate

Intervention Type: DRUG

Methotrexate will be administered at a stable dose that was initiated at least 4 weeks prior to Baseline, at investigator's discretion.

csDMARDs

Intervention Type: DRUG

csDMARDs (at investigator's discretion) will be administered at a stable dose that was initiated at least 4 weeks prior to Baseline, at investigator's discretion.

Interventions

Tocilizumab

Tocilizumab will be administered at a dose of 162 mg as SC injection once a week.

Intervention Type: DRUG

Methotrexate

Methotrexate will be administered at a stable dose that was initiated at least 4 weeks prior to Baseline, at investigator's discretion.

Intervention Type: DRUG

csDMARDs

csDMARDs (at investigator's discretion) will be administered at a stable dose that was initiated at least 4 weeks prior to Baseline, at investigator's discretion.

Intervention Type: DRUG

Other Intervention Names

RoActemra; RO4877533

Eligibility Criteria

Inclusion Criteria

• Participants with a diagnosis of active rheumatoid arthritis according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria and receiving outpatient treatment
• Oral corticosteroids (</= 10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs), and permitted csDMARDs are allowed at a stable dose for at least 4 weeks prior to Baseline
• At Screening either CRP >/=10 mg/L or ESR >/=20 mm/h and SJC >/=3 (based on 44 joints)
• Inadequate response (IR) to tumor necrosis factor, abatacept and/or non-biological DMARDs

Exclusion Criteria

• Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline
• Rheumatic autoimmune disease other than rheumatoid arthritis; Secondary Sjögren's syndrome with rheumatoid arthritis is permitted
• Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
• Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16
• Prior history of or current inflammatory joint disease other than rheumatoid arthritis
• Exposure to tocilizumab at any time prior to Baseline
• Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever was longer) of Screening
• Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies or any alkylating agents such as chlorambucil, or with total lymphoid irradiation
• Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline
• Intraarticular or parenteral corticosteroids within 4 weeks prior to Baseline
• Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline
• History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
• Serious uncontrolled concomitant disease or other significant condition
• History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease
• Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
• Any infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening
• Active tuberculosis requiring treatment within the previous 3 years
• Positive for hepatitis B or C
• Primary or secondary immunodeficiency disorder
• Active cancer, or cancer diagnosed within the previous 10 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised or cured), or breast cancer diagnosed within the previous 20 years
• History of alcohol, drug, or chemical abuse within 1 year prior to Screening
• Neuropathies or other conditions that might interfere with pain evaluation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Amiens, , France

Bordeaux, , France

Brest, , France

Caen, , France

Cahors, , France

Clermont-Ferrand, , France

Échirolles, , France

La Source, , France

Le Mans, , France

Lille, , France

Limoges, , France

Lomme, , France

Lyon, , France

Marseille, , France

Marseille, , France

Metz-Tessy, , France

Monaco, , France

Montpellier, , France

Mulhouse, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Rennes, , France

Rouen, , France

Saint-Mandé, , France

Saint-Priest-en-Jarez, , France

Strasbourg, , France

Thonon-les-Bains, , France

Toulouse, , France

Vandœuvre-lès-Nancy, , France

Countries

France

References

Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.

Reference Type: DERIVED

PMID: 30649524 (View on PubMed)

Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443.

Reference Type: DERIVED

PMID: 29244149 (View on PubMed)

Other Identifiers

2013-001718-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28693

Identifier Type: -

Identifier Source: org_study_id