A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 20, 2013

Primary Completion Date

July 10, 2016

Study Completion Date

July 10, 2016

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Azathioprine

Participants may receive azathioprine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.

DRUG

Chloroquine

Participants may receive chloroquine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.

DRUG

Hydroxychloroquine

Participants may receive hydroxychloroquine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.

DRUG

Leflunomide

Participants may receive leflunomide as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.

DRUG

Methotrexate

Participants may receive methotrexate as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.

DRUG

Sulfasalazine

Participants may receive sulfasalazine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.

DRUG

Tocilizumab

Participants will receive tocilizumab at a fixed dose of 162 mg SC QW either as monotherapy or in combination with non-biologic DMARDs.

Trial Locations (10)

11527

Hippokratio Hospital; 2Nd Internal Medicine, Athens

115 27

District Gen. Hosp. of Athens Laiko; A Propedeutic Internal Medicine Clinic & Research Center, Athens

Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens, Athens

124 62

ATTIKO Hospital_4th University Internal Medicine Clinic, Haidari

711 10

Uni General Hospital of Heraklion; Medicine and Rheumatology Clinical Immunology and Allergy Dept, Heraklion

455 00

Uni Hospital of Ioannina; Rheumatology, Ioannina

411 10

University General Hospital of Larissa; Rheumatology Unit, Larissa

265 04

University Hospital of Patras; Rheumatology, Pátrai

544 65

EUROMEDICA Geniki Kliniki Thessalonikis; Rheumatology Department, Thessaloniki

546 42

General Hospital of Thessaloniki HIPPOKRATIO; Clinical Immunology Unit,2nd Dept of Internal Medicine, Thessaloniki

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01941095 - A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter