NCT02046616View on ClinicalTrials.gov

A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

PHASE3CompletedINTERVENTIONAL
Enrollment

133

Participants

Timeline

Start Date

May 28, 2014

Primary Completion Date

September 13, 2016

Study Completion Date

September 13, 2016

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Tocilizumab

Tocilizumab 162 mg will be administered subcutaneously QW.

DRUG

Methotrexate

Methotrexate dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.

DRUG

Non-Biologic DMARDs

Participants will receive non-biologic DMARDs (same non-biologic DMARD that participant was receiving at time of study entry). Dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.

Trial Locations (27)

2600

Glostrup Hospital, Reumatologisk Afdeling, Ambulatoriet, Glostrup Municipality

2900

Gentofte Hospital, Medicinsk Afd. C, Klinik for Gigt- og Rygsygdomme, Hellerup

3004

Drammen sykehus Vestre Viken HF, Revmatologisk avd., Drammen

4300

Holbæk Sygehus, Medicinsk Afd., Reumatologisk Amb.15-2, Holbæk

4600

Sjællands Universitetshospital, Køge; Reumatologisk Afdeling, Køge

5000

Odense Universitetshospital, Reumatologisk Afdeling C, Ambulatoriet, Odense

5053

Haukeland Universitetssykehus; Revmatologisk Avdeling, Bergen

5700

Svendborg Sygehus, Reumatologisk Ambulatorium, Svendborg

6017

Ålesund Sykehus; Revmatologisk Avdeling, Ålesund

7030

St. Olavs Hospital; Revmatologisk avdeling, Trondheim

9000

Aalborg Universitetshospital Nord, Reumatologisk Afdeling, Aalborg

40620

Keski-Suomen Keskussairaala; Sisätautien Klinikka, Jyväskylä

53130

Lappeenranta Central Hospital; Outpatient Clinic of Internal Medicine, Lappeenranta

58185

Uni Hospital Linkoeping; Dept. of Rheumatology, Linköping

70185

Örebro Uni Hospital; Rheumatology, Örebro

72189

Västmanlands sjukhus Västerås, Reumatologkliniken, Västerås

75185

Akademiska sjukhuset, Reumatologkliniken, Uppsala

80210

Central Hospital of Pohjois-Karjala; Outpatient Clinic of Rheumatology, Joensuu

90220

Oulu University Hospital; Rheumatology, Oulu

00290

Helsinki University Central Hospital; Rheumatology Clinic, Helsinki

05800

Kiljavan Lääketutkimus Oy, Hyvinkää

0370

Diakonhjemmet; Reumatolgisk Avdeling, Oslo

551 85

Länssjukhuset Ryhov; Ortoped- och Reumatolog kliniken, Jönköping

221 85

Skånes Universitetssjukhus Lund; Reumatologkliniken, Lund

205 02

Skånes Universitetssjukhus Malmö; Reumatologkliniken, Malmo

272 81

Simrishamns Sjukhus, Simrishamn

171 76

Karolinska Sjukhuset; Reumatologkliniken D2-1, Stockholm

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02046616 - A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | Biotech Hunter | Biotech Hunter