Crohn's Disease
Conditions
Sponsors
AbbVie GK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subject >=15 years of age at the time of informed consent. 2)Subject with Crohn's disease who received induction treatment of commercially available Humira (160 mg initially and 80 mg at 2 weeks after initial dose), achieved response after initial dose, and then lost response during maintenance treatment with Humira. 3)Subject with elevated CRP at Screening. 4)If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after the last dose of study drug. 5)Subject has a negative Tuberculosis (TB) Screening Assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 21 days of an ongoing TB prophylaxis (in such case, screening period can be prolonged until 21 days past after initiation of prophylaxis and study drug is administered) or have documented completion of a full course of TB prophylaxis, prior to Week 0.
Exclusion criteria
Exclusion criteria: 1)Subject with suspicion of colitis other than Crohn's disease. 2)Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded). 3)Subject with abscess or suspicion of abscess, or subject with infection(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of the subjects who achieved Clinical Response at week 8. Crohn's Disease Activity Index (CDAI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of the subjects who achieved clinical remission. Crohn's Disease Activity Index (CDAI) | — |
Outcome results
None listed