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Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis (Merit-UC)

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ClinicalTrials.gov Identifier: NCT01393405
Recruitment Status : Completed
First Posted : July 13, 2011
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Hans Herfarth, MD, PhD, University of North Carolina, Chapel Hill

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Intervention: Drug: Methotrexate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
256 patients were assessed for eligibility between February 2012 and May 2016 at 37 sites across the US. 76 met exclusion criteria and one patient withdrew consent during screening.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Induction Period (Week 1-16) Steroid taper for 12 weeks and 25 mg MTX sq once weekly + 1 mg folic acid daily
Methotrexate Maintenance (Week 17-48) 25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
Placebo Maintenance (Week 17-48) Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine

Participant Flow for 2 periods

Period 1:   Induction Period (week1-16)
    Induction Period (Week 1-16)   Methotrexate Maintenance (Week 17-48)   Placebo Maintenance (Week 17-48)
STARTED   179   0   0 
COMPLETED   84   0   0 
NOT COMPLETED   95   0   0 
Lack of Efficacy                70                0                0 
Adverse Event                16                0                0 
Withdrawal by Subject                9                0                0 

Period 2:   Maintenance Period Week
    Induction Period (Week 1-16)   Methotrexate Maintenance (Week 17-48)   Placebo Maintenance (Week 17-48)
STARTED [1]   0   44   40 
COMPLETED   0   15   16 
NOT COMPLETED   0   29   24 
Lack of Efficacy                0                22                22 
Adverse Event                0                5                2 
Withdrawal by Subject                0                1                0 
Lost to Follow-up                0                1                0 
[1] 84 patients completed the induction period and were randomized to maintenance period



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Induction Period (Week 1-16) Steroid taper for 12 weeks and 25 mg MTX sq once weekly + 1 mg folic acid daily

Baseline Measures
   Induction Period (Week 1-16) 
Overall Participants Analyzed 
[Units: Participants]
 179 
Age 
[Units: Years]
Mean (Full Range)
 42 
 (19 to 74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      69  38.5% 
Male      110  61.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      10   5.6% 
Not Hispanic or Latino      169  94.4% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      3   1.7% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      14   7.8% 
White      155  86.6% 
More than one race      0   0.0% 
Unknown or Not Reported      7   3.9% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   179 
Calprotectin week 0 (Induction period) or week 16 (Maintenance period) 
[Units: Mg/kg]
Mean (Standard Deviation)
 612  (524) 
Site of disease 
[Units: Participants]
Count of Participants
 
Left colon      86  48.0% 
Pancolitis      93  52.0% 


  Outcome Measures

1.  Primary:   Relapse Free Survival Week 17-48   [ Time Frame: 48 weeks ]

2.  Secondary:   Mucosal Healing at Week 48.   [ Time Frame: 48 weeks ]

3.  Secondary:   Relapse of Disease Between Week 17-48   [ Time Frame: 48 weeks ]

4.  Other Pre-specified:   Calprotectin Levels <250 mcg/g Stool in Patients in Response or in Remission at Week 16 With Calprotectin Levels ≥ 250 mcg/g Stool at Screening   [ Time Frame: 16 weeks ]

5.  Other Pre-specified:   Calprotectin Levels <250 mcg/g Stool in Patients in Response or in Remission at Week 48 With Calprotectin Levels > 250 mcg/g Stool at Screening   [ Time Frame: 48 weeks ]

6.  Other Pre-specified:   Calprotectin Levels < 50 mcg/g Stool in Patients in Remission at Week 16 With Calprotectin Levels ≥ 250 mcg/g Stool at Screening   [ Time Frame: 16 weeks ]

7.  Other Pre-specified:   Calprotectin Levels < 50 mcg/g Stool in Patients in Remission at Week 48 With Calprotectin Levels ≥ 250 mcg/g Stool at Screening   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no limitations for this trial


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Hans Herfarth
Organization: University of North Carolina, Chapel Hill, NC
phone: 9199666806
e-mail: hherf@med.unc.edu


Publications:

Responsible Party: Hans Herfarth, MD, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01393405     History of Changes
Other Study ID Numbers: 09-2044
1U01DK092239-01 ( U.S. NIH Grant/Contract )
First Submitted: July 11, 2011
First Posted: July 13, 2011
Results First Submitted: January 9, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018