Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCAR

Hoffmann-La Roche20 sites in 1 country150 target enrollmentJanuary 30, 2014

ConditionsRheumatoid Arthritis

InterventionsNon-Biologic DMARDs Tocilizumab Methotrexate

DrugsNon-Biologic DMARDs Tocilizumab Methotrexate

Overview

Phase: Phase 3
Intervention: Non-Biologic DMARDs
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 150
Locations: 20
Primary Endpoint: Percentage of Participants With Adverse Events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This multi-center, open-label single arm Phase IIIb study will evaluate the safety and efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) in participants with rheumatoid arthritis (RA) with an inadequate response to non-biologic DMARDs.

Registry

clinicaltrials.gov

Start Date

January 30, 2014

End Date

May 26, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
•Oral corticosteroids (≤10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for greater than or equal to (≥\]) 4 weeks prior to Baseline.
•Use of effective contraception throughout the study as defined by protocol; female participants of childbearing potential cannot be pregnant.

Exclusion Criteria

•Presence of clinically significant medical conditions.
•History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease that might predispose to perforation.
•Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections.
•Any infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.
•Clinically significant findings on laboratory tests.
•Positive hepatitis B surface antigen or hepatitis C antibody.
•Active tuberculosis requiring treatment within the previous 3 years.
•Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, 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.

Arms & Interventions

Tocilizumab Alone or in Combination with Methotrexate or DMARD

Participants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.

Intervention: Non-Biologic DMARDs

Tocilizumab Alone or in Combination with Methotrexate or DMARD

Participants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.

Intervention: Tocilizumab

Tocilizumab Alone or in Combination with Methotrexate or DMARD

Participants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.

Intervention: Methotrexate

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events

Time Frame: Baseline up to Week 32

An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events.

Secondary Outcomes

Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
Percentage of Participants Achieving an ACR50 Response(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
Percentage of Participants Achieving an ACR70 Response(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
Percentage of Participants Achieving an ACR90 Response(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24))
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons(From Week 16 and before Week 20; From Week 20 and before Week 24)
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons(From Week 16 and before Week 20; From Week 20 and before Week 24)
Time to Discontinuation or First Dose Reduction of Corticosteroids or NSAIDs(Baseline up to Week 32)
Percentage of Participants With Anti-Tocilizumab Antibodies(Baseline, Weeks 12 and 24, early withdrawal (up to Week 24), follow-up visit (8 weeks after last dose of tocilizumab, up to 32 weeks))
Serum Levels of Tocilizumab(Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks))
Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)(Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks))
Patient Global Assessment of Disease Activity VAS Scores(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24))
Patient Pain VAS Scores(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24))
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24))
Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records(Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24))
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score(Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24))