A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

PHASE4CompletedINTERVENTIONAL
Enrollment

261

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions
Rheumatoid Arthritis
Interventions
DRUG

methotrexate

orally, Week 1 - 16

DRUG

methotrexate

orally, Week 17-28

DRUG

placebo

methotrexate placebo orally, Week 17-28

DRUG

tocilizumab [RoActemra/Actemra]

8 mg/kg iv every 4 weeks, 28 weeks

Trial Locations (54)

10310

Cáceres

11009

Cadiz

12540

Villarreal

14004

Córdoba

15006

A Coruña

15706

Santiago de Compostela

18003

Granada

18014

Granada

19002

Guadalajara

24071

León

27004

Lugo

28007

Madrid

28031

Madrid

28034

Madrid

28040

Madrid

28041

Madrid

28046

Madrid

28342

Valdemoro

28805

Alcalá de Henares

28905

Madrid

28942

Fuenlabrada

29009

Málaga

30120

El Palmar

30203

Cartagena

35020

Las Palmas de Gran Canaria

36214

Vigo

37007

Salamanca

38010

Santa Cruz de Tenerife

39300

Torrelavega

41009

Seville

41013

Seville

45004

Toledo

46009

Valenica

46010

Valencia

46017

Valencia

46940

Manises

48013

Bilbao

48903

Barakaldo

48960

Galdakao

02006

Albacete

03314

Orihuela

03186

Torrevieja

03570

Villajoyosa

06080

Badajoz

06800

Mérida

07701

Menorca

08915

Badalona

08003

Barcelona

08025

Barcelona

08035

Barcelona

08036

Barcelona

08907

Barcelona

08402

Granollers

08221

Terrassa

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01399697 - A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate | Biotech Hunter | Biotech Hunter