Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis

PHASE2CompletedINTERVENTIONAL
Enrollment

179

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

April 30, 2017

Study Completion Date

April 30, 2017

Conditions
Ulcerative Colitis
Interventions
DRUG

Methotrexate

"Induction period (week 1-16) (Open label):~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily~Maintenance period (week 17-48) (Randomization):~25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine or Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"

Trial Locations (31)

10029

Mt Sinai School of Medicine, New York

17033

Penn State University, State College

19104

University of Pennsylvania, Philadelphia

20815

Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research, Chevy Chase

21201

University of Maryland, Baltimore

27599

University of North Carolina, Chapel Hill

28207

Charlotte Gastroenterology & Hepatology, Charlotte

28801

Asheville Gastroenterology Associates, Asheville

29425

Medical University of South Carolina, Charleston

30342

Atlanta Gastroenterology, Atlanta

32789

Shafran Gastroenterology, Winter Park

40202

University of Louisville, Louisville

40536

University of Kentucky, Lexington

44060

Great Lakes Gastroenterology, Mentor

44106

Case Western Reserve University, Cleveland

46202

Indiana University IU Health, Indianapolis

48377

Henry Ford Health System, Novi

52242

University of Iowa, Iowa City

53792

University of Wisconsin, Madison

55446

Minnesota Gastroenterology, Plymouth

55905

Mayo Clinic, Rochester

60611

Northwestern University, Chicago

60637

The University of Chicago, Chicago

77030

Baylor University, Houston

80045

University of Colorado, Denver

84132

University of Utah, Salt Lake City

90033

University of Southern California, Los Angeles

98104

Harborview Medical Center, Seattle

98195

University of Washington, Seattle

02114

Massachusetts General Hospital, Boston

03756

Dartmouth College, Lebanon

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of North Carolina, Chapel Hill

OTHER

NCT01393405 - Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis | Biotech Hunter | Biotech Hunter