Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

PHASE3CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

September 30, 2008

Conditions
Crohn's Disease
Interventions
BIOLOGICAL

adalimumab

At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab 40 mg eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.

BIOLOGICAL

placebo

At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.

BIOLOGICAL

adalimumab

At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab or placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8. In the Open-Label arm, interventions were either adalimumab 40 mg SC eow or adalimumab 40 mg SC weekly. There was no placebo intervention post Week 52.

Trial Locations (21)

2820

Bonheiden

8800

Roeselare

10128

Torino

11021

Great Neck

12200

Berlin

20815

Chevy Chase

22559

Hamburg

24105

Kiel

30342

Atlanta

55446

Plymouth

60637

Chicago

55905-0002

Rochester

65265-3726

Mexico

A - 1090

Vienna

B 3000

Leuven

T2N 4N1

Calgary

V6Z 2K5

Vancouver

B3H 1V7

Halifax

M3N 2V7

Toronto

59 037

Lille

1105 AZ

Amsterdam

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY

NCT00348283 - Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon | Biotech Hunter | Biotech Hunter