A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis

PHASE2CompletedINTERVENTIONAL
Enrollment

161

Participants

Timeline

Start Date

February 28, 2001

Primary Completion Date

August 31, 2002

Study Completion Date

August 31, 2004

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Cyclophosphamide

Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17

DRUG

Methotrexate

Participants will receive \>= 10 mg/week methotrexate orally up to 24 weeks

OTHER

Placebo Cyclophosphamide

Participants will receive placebo in place of cyclophosphamide on Days 3 and 17

OTHER

Placebo Methotrexate

Participants will receive weekly oral placebo in place of Methotrexate

OTHER

Placebo Rituximab

Participants will receive placebo in place of rituximab on days 1 and 15

DRUG

Rituximab

Participants will receive 1g infusions of rituximab on Days 1 and 15

Trial Locations (33)

2010

Darlinghurst

2217

Kogarah

3590

Diepenbeek

4000

Liège

5011

Woodville

9000

Ghent

16132

Genova

19002

Guadalajara

25123

Brescia

28007

Madrid

28046

Madrid

31048

Haifa

34354

Haifa

38320

San Cristóbal de La Laguna

40882

Ratingen

41014

Seville

41100

Modena

53100

Siena

65191

Wiesbaden

R3A 1M4

Winnipeg

M5G 1X5

Toronto

H2L 1S6

Montreal

128 50

Prague

04107

Leipzig

2333 ZA

Leiden

20-022

Lublin

61-545

Poznan

02-637

Warsaw

50-556

Wroclaw

WS11 5XY

Cannock

LS1 3EX

Leeds

W1P 9PG

London

ST6 7AG

Stoke-on-Trent

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02693210 - A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter