A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 30, 2014

Primary Completion Date

May 26, 2016

Study Completion Date

May 26, 2016

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Non-Biologic DMARDs

Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study and is at the investigator's discretion.

DRUG

Tocilizumab

Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 24 weeks.

DRUG

Methotrexate

Methotrexate will be administered per investigator's discretion.

Trial Locations (20)

7609 PP

ZGT Almelo; Reumatologie, Almelo

1056 AB

Jan Van Breemen Instituut, Amsterdam

7334 DZ

Gelre Ziekenhuizen; Reumatologie, Apeldoorn

4819 EV

Amphia ziekenhuis, locatie langendijk, Breda

3318AT

Albert Schweitzer Ziekenhuis ; Dordwijk, Dordrecht

9700RB

Universitair Medisch Centrum Groningen; Department of Rheumatology, Groningen

9728 MG

Martini Ziekenhuis, Groningen

2035 RC

Kennemer Gasthuis, Haarlem

6419 PC

Atrium Medisch Centrum, Heerlen

2134 TM

Spaarne Ziekenhuis; Inwendige Geneeskunde, Hoofddorp

8934 AD

Medisch Centrum Leeuwarden; Reumatology, Leeuwarden

2333 ZA

Academisch Ziekenhuis Leiden; Dept of Rheumatology, Leiden

6202 ZA

Maastricht University Medical Centre; Rheumatology, Maastricht

3015 CE

Erasmus Medisch Centrum; Reumatologie, Rotterdam

3079 DZ

Maasstadziekenhuis; Reumatologie, Rotterdam

3118 JH

Vlietland Hospital, Schiedam

8601 ZK

Antonius Ziekenhuis Sneek; Department of Rheumatology, Sneek

2545 CH

Leyenburg Ziekenhuis; Internal Medecine, The Hague

2597 AX

St. Bronovo-Nebo, The Hague

3584 GA

University Medical Centre Utrecht; Reumatologie en Klinische Immunologie, Utrecht

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01987479 - A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter