NCT00634933 - Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis | Biotech Hunter

Enrollment

222

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

February 28, 2010

Study Completion Date

October 31, 2012

Conditions

Arthritis, Rheumatoid

Interventions

DRUG

TRU-015

IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).

DRUG

Methylprednisolone

IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms).

DRUG

Prednisone

Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms)

DRUG

TRU-015

IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms).

DRUG

Methylprednisolone

IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms).

DRUG

Prednisone

Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 2a) and Week 36 (both arms); corresponding Oral Placebo at Week 12 (Arm 2b) and Week 24 (both arms).

DRUG

TRU-015

IV 800 mg TRU-015 at Week 24 (both arms) and Week 36 (arm 3a); corresponding IV Placebo at Baseline (both arms), Week 12 (both arms) and Week 36 (arm 3b).

DRUG

Methylprednisolone

IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms), and Week 36 (arm 3a); corresponding IV Placebo at Week 12 (arm 3b) and Week 36 (arm 3b).

DRUG

Prednisone

Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms) and Week 36 (arm 3a); corresponding Oral Placebo at Week 12 (Arm 3b) and Week 36 (arm 3b).

Trial Locations (65)

1023

Pfizer Investigational Site, Budapest

1200

Pfizer Investigational Site, Brussels

4000

Pfizer Investigational Site, Liège

4043

Pfizer Investigational Site, Debrecen

4400

Pfizer Investigational Site, Nyíregyháza

11000

Pfizer Investigational Site, Belgrade

13210

Pfizer Investigational Site, Syracuse

15090

Pfizer Investigational Site, Wexford

16801

Pfizer Investigational Site, State College

17822

Pfizer Investigational Site, Danville

18250

Pfizer Investigational Site, Niška Banja

21100

Pfizer Investigational Site, Mexicali

26301

Pfizer Investigational Site, Clarksburg

28210

Pfizer Investigational Site, Charlotte

31059

Pfizer Investigational Site, Toulouse

32117

Pfizer Investigational Site, Daytona Beach

34059

Pfizer Investigational Site, Montpellier

34474

Pfizer Investigational Site, Ocala

34684

Pfizer Investigational Site, Palm Harbor

39232

Pfizer Investigational Site, Flowood

39245

Pfizer Investigational Site, Vogelsang

44100

Pfizer Investigational Site, Guadalajara

44143

Pfizer Investigational Site, Mayfield Village

44158

Pfizer Investigational Site, Guadalajara

44650

Pfizer Investigational Site, Guadalajara

44690

Pfizer Investigational Site, Guadalajara

45239

Pfizer Investigational Site, Essen

45245

Pfizer Investigational Site, Cincinnati

49546

Pfizer Investigational Site, Grande Rapids

50924

Pfizer Investigational Site, Cologne

58070

Pfizer Investigational Site, Morelia

58701

Pfizer Investigational Site, Minot

60612

Pfizer Investigational Site, Chicago

62704

Pfizer Investigational Site, Springfield

63110

Pfizer Investigational Site, St Louis

73112

Pfizer Investigational Site, Oklahoma City

75231

Pfizer Investigational Site, Dallas

75674

Pfizer Investigational Site, Paris

78232

Pfizer Investigational Site, San Antonio

80020

Pfizer Investigational Site, Culiacán

85253

Pfizer Investigational Site, Paradise Valley

90048

Pfizer Investigational Site, Los Angeles

90095

Pfizer Investigational Site, Los Angeles

90404

Pfizer Investigational Site, Santa Monica

97070

Pfizer Investigational Site, Würzburg

97080

Pfizer Investigational Site, Würzburg

400006

Pfizer Investigational Site, Cluj-Napoca

700081

Pfizer Investigational Site, Iași

35294-7201

Pfizer Investigational Site, Birmingham

93454-6945

Pfizer Investigational Site, Santa Maria

01605

Pfizer Investigational Site, Worcester

01608

Pfizer Investigational Site, Worcester

18711-3762

Pfizer Investigational Site, Wilkes-Barre

V1W 4V5

Pfizer Investigational Site, Kelowna

V1Y 3G8

Pfizer Investigational Site, Kelowna

R3A 1M3

Pfizer Investigational Site, Winnipeg

B1S 3N1

Pfizer Investigational Site, Sydney

N2M 5N6

Pfizer Investigational Site, Kitchener

G8Z 1Y2

Pfizer Investigational Site, Trois-Rivières

S7N 0W8

Pfizer Investigational Site, Saskatoon

06700

Pfizer Investigational Site, Mexico City

2333 ZA

Pfizer Investigational Site, Leiden

020983

Pfizer Investigational Site, Bucharest

011172

Pfizer Investigational Site, Bucharest