Crohn's Disease
Conditions
Interventions
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Injection*
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Sponsors
Abbott Laboratories
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient will be eligible for study participation if he/she meets the following criteria: Patients must have successfully enrolled and completed the M02 - 404 or M04-691 study. Female patients: Must continue to utilize a highly effective method of birth control throughout the study and for 70 days after study completion or must not be of childbearing potential, defined as postmenopausal at least two years, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Patients must be able and willing to give written informed consent and to comply with the requirements of this study protocol. Adequate cardiac, renal and hepatic function as determined by principal investigator and demonstrated by screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: There were no exclusion criteria for this study since patients participated in the M02-404 and M04-691 studies and were screened against the exclusion criteria of that study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term maintenance response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in Protocol M02-404 and Protocol M04-691.;Secondary Objective: ;Primary end point(s): Clinical assessment of CDAI scores and other efficacy measures for maintenance of clinical response and remission during the open-label extension period following year one (1) will be evaluated. Quality of life parameters, including IBDQ, will also be summarized. | — |
Countries
Belgium, Denmark, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed