A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
- Conditions
- inflammatory bowel disease (IBD)10018027Ulcerative colitis
- Registration Number
- NL-OMON47464
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 19
Main Inclusion:
1. Subject must be able and willing to provide written informed consent and comply with the
requirements of this study protocol.;2. Male or female >= 18 and <= 75 years of age at the Baseline visit.;3. Subject with a diagnosis of UC for 90 days or greater prior to Baseline, confirmed by endoscopy (colonoscopy or flexible sigmoidoscopy) during the Screening Period, with exclusion of current infection, dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.;4. Active UC with a Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 (confirmed by
central reader) despite concurrent treatment with at least one of the following oral corticosteroids or immunosuppressants as defined below:
- Subject taking oral corticosteroids, excluding budesonide or beclomethasone:
Oral corticosteroid dose must be <= 40 mg/day (prednisone or equivalent):
Dose > 10 and <= 40 mg/day: dose has been stable for at least 7 days prior to Baseline and the duration of the current steroid course has been at least 14 days prior to Baseline.
Dose <= 10 mg/day, dose has been stable for at least 10 days prior to Baseline and the duration of the current steroid course has been at least 14 days prior to Baseline.;- Subject taking oral budesonide: Dose must not exceed 9 mg/day:
Dose >= 6 mg/day, dose has been stable for at least 7 days prior to Baseline and the duration of the current steroid course has been at least 14 days prior to Baseline.
Dose < 6 mg/day, dose has been stable for at least 10 days prior to Baseline and the duration of the current steroid course has been at least 14 days prior to Baseline.;• Subject taking oral beclomethasone: dose must not exceed 5 mg/day;
* Dose has been stable for at least 7 days prior to Baseline and the duration of the current steroid course has been at least 14 days prior to Baseline.;or,
At least a consecutive 42-day course of azathioprine, 6-mercaptopurine (6-MP) or injectable
methotrexate (MTX) prior to Baseline, with a stable dose for at least 28 days prior to Baseline of
azathioprine >= 1.5 mg/kg/day or 6-MP >= 1 mg/kg/day (rounded to the nearest available tablet or half tablet formulation) or a documented 6-TGN level of at least 230 pmol/8 x 108 RBC to clarify a therapeutic level was achieved on the current dosing regimen or MTX >= 15 mg/week (Subcutaneous [SC]/Intramuscular [IM]), or a dose that is
the highest tolerated by the subject (e.g., due to leukopenia, elevated liver enzymes, nausea)
during that time.
Note: If a subject is taking (both an oral corticosteroid and an immunosuppressant listed above)BOTH of the drugs need to meet the above dosing and duration of use criteria. Oral MTX use is allowed during the study (at a stable dose for 28 days prior to Baseline), however prior or current use of oral MTX is not sufficient for inclusion into the study.
or,
Concurrent therapy with oral corticosteroids or immunosuppressants (azathioprine, 6-MP or
SC/IM MTX) is not required for subjects not currently taking these medications who were
previously treated during the past 1 year and have confirmed documentation of failure to
respond, or were previously treated during the past 5 years and have confirmed documentation
indicating lack of tolerability.;5. Subject may be included if they have previously experience
Main Exclusion:
1. Subject with diagnosis and/or history of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).;2. Current diagnosis of fulminant colitis and/or toxic megacolon.;3. Subject with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.;4. Received therapeutic enema or suppository, other than required for endoscopy, within 7 days prior to the Screening endoscopy and during the remainder of the Screening Period.;5. History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch,
or ileostomy or is planning bowel surgery.;6. Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Baseline.
7. Positive pregnancy test at Screening (serum) or Baseline (urine).
8. Female who is breast-feeding or considering becoming pregnant during the study.
9. History of clinically significant drug or alcohol abuse in the last 12 months.
10. Subject on azathioprine, 6-MP, MTX, or another immunosuppressant (e.g., thalidomide) who:
- Has not been on these medications for at least 42 days prior to Baseline; or
- Has not been on stable doses of these medications for at least 28 days prior to Baseline; or
- Has discontinued these medications within 14 days of Baseline.
- Has not been on these medications for at least 42 days prior to Baseline; or
- Has not been on stable doses of these medications for at least 28 days prior to Baseline; or
- Has discontinued these medications within 14 days of Baseline.;11. Subject on oral aminosalicylates who:
- Has not been on stable doses of these medications for at least 14 days prior to Baseline; or
- Has discontinued use of aminosalicylates within 14 days of Baseline.;12. Subject on oral corticosteroid > 40 mg/day (prednisone or equivalent) or subject on oral budesonide > 9 mg/day; or subject on oral beclomethasone > 5 mg/day; or
- Subject taking an oral corticosteroid (excluding budesonide):
dose > 10 mg/day, but has not been on a stable dose for at least 7 days prior to Baseline; or
dose > 10 mg/day, but has not been on a current steroid course of at least 14 days in
duration prior to Baseline; or
dose <= 10 mg/day or equivalent, but has not been on a stable dose for at least 10 days prior
to Baseline; or
dose <= 10 mg/day or equivalent but has not been on a current steroid course of at least
14 days in duration prior to Baseline, or;- Subject taking oral budesonide:
dose >= 6 mg/day, but has not been on a stable dose for at least 7 days prior to Baseline; or
dose >= 6 mg/day, but has not been on a current steroid course of at least 14 days in duration
prior to Baseline; or
dose < 6 mg/day dose but has not been on a stable dose of at least 10 days prior to
Baseline; or
dose < 6 mg/day but has not been a current steroid course of at least 14 days in duration
prior to Baseline; or;Has been taking both oral budesonide (or oral becomethasone) and oral prednisone (or equivalent) simultaneously
and/or has discontinued use of corticosteroids within 14 days of Baseline.;13. Received intravenous corticosteroids within 14 days prior to Screening or during the Screening
Period.;14. Positive Clostridium difficile (C. difficile) toxin stool assay during the Screening Period.;15. Currently receiving total parenteral nutrition (TPN).;16. Subject who received any investigational agent or procedure (i
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method