Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease (APPRECIA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01564823|
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Crohn´s Disease||Drug: Metronidazole Drug: Azathioprine Drug: Adalimumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Metronidazole + Azathioprine.
Metronidazole, oral intake. 250 mg/8h. 3 months. Azathioprine, 2.5 mg/weight kg/day, oral intake. All study.
Metronidazole: 250 mg/8h. 3 months.
Other Name: Flagyl (Metronidazole)
Azathioprine: 2.5 mg/kg of weight/day. 3 months.
Other Name: Imurel (Azathioprine)
Active Comparator: Metronidazole + Adalimumab
Metronidazole Oral Intake. 250 mg/8h. During 3 months. Adalimumab Subcutaneous 160 mg and 80 mg 2wk. Then 40 mg during 2wk as maintenance.
Metronidazole 250 mg/8h 3 months
Other Name: Flagyl (Metronidazole)
Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance.
Other Name: Humira (Adalimumab)
- Number of endoscopic recurrences [ Time Frame: 52 weeks after the begin of the study ]Evaluation of the effectiveness on prevention of endoscopic recurrence evaluated as changes in the Rutgeerts Index.
- Number of Crohns´disease remission [ Time Frame: 24 weeks ]% of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azathioprin treatment
- Number of postsurgical recurrences [ Time Frame: 52 week ]Evaluation of the Adalimumab efficiency on preventing postsurgical recurrence with Magnetic Resonance Enterography
- number of hospitalized patients [ Time Frame: 52 weeks ]Comparing hospitalization percentage in patients using adalimumab or azathioprin after 52 weeks of treatment
- Concentration of activity markers [ Time Frame: 24 weeks ]Evaluating changes in markers such as reactive c-protein, variable surface glycoprotein , faecal calprotectin, etc.
- Number of surgeries [ Time Frame: Until 52 week ]Comparing % of patients who needs surgery on Adalimumab vs Azatioprine
- SIBDQ and EuroQOL indexes [ Time Frame: 24 Weeks ]Quality of life
- Number of Adverse event reports [ Time Frame: 52 weeks ]Comparison of safety of Adalimumab versus Azatioprine.
- Number of Crohns´disease remission [ Time Frame: 52 weeks ]% of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azatioprine treatment
- Concentration of activity markers [ Time Frame: 52 weeks ]Evaluating changes in markers such as reactive c-protein, VSG, faecal calprotectine, etc
- SIBDQ and EuroQOL indexes [ Time Frame: 52 weeks ]Quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564823
|Principal Investigator:||Pilar Nos, MD||Hospital Universitari i Politecnic La Fe (Valencia, Spain)|