A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I

• Conditions: In the present study, the corticosteroid-sparing effect of certolizumab pegol will be assessed in patients with moderate to severe Crohn’s disease who have received initial acute corticosteroid therapy (prednisone or prednisolone) for induction of remission.; MedDRA version: 8.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2006-003870-88-DE
• Lead Sponsor: CB Pharma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

Patient is able to understand the information provided to them and who have given written informed consent to the study. Patient is able to understand and complete self-administered questionnaires. Men and women, age 18 years or older
A diagnosis of moderate to severe Crohn's disease (CDAI score of >= 220 - < =450) during the run-in period. The patient is a candidate for treatment with prednisone or prednisolone therapy, but is not on maintenance corticosteroid therapy
If the patient is on an immunosuppressant (azathioprine, 6-mercaptopurine and methotrexate are allowed immunosuppressants), the dose has to have been stable for at least 8 weeks prior to screening and is expected to remain stable during the study. If the patient is on a 5-ASA analogue for Crohn’s disease, the dose has to have been stable for at least 4 weeks prior to screening and is expected to remain stable during the study. If female, the patient is either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptive; intrauterine device; barrier and spermicide—abstinence is not an acceptable method). Patients must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab.

Are the trial subjects under 18?
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

Patients who were primary non-responders to previous treatment with an anti-TNF drug are excluded. Patients with previous certolizumab pegol exposure are excluded.
If a patient received = 3 injections of anti-TNF therapy (other than certolizumab pegol) and responded to treatment, but discontinued that treatment for reasons other than loss of response or hypersensitivity reaction, the patient may be included in the study.
Any patient receiving = 3 injections of anti-TNF (other than certolizumab pegol) in the past 6 months must be reviewed by the UCB Study Physician prior to being included in the study.

Active or draining fistula present at screening. On maintenance corticosteroid therapy. Symptomatic obstructive intestinal strictures. Functional colostomy or ileostomy (patients who have a temporary stoma in the past, which has been reversed, are eligible to enter the study).Bowel resection within 3 months of starting the study medication. Current total parenteral nutrition.Short bowel syndrome.Positive stool laboratory results for pathogens.Antibiotic treatment for Crohn’s Disease within 2 weeks prior to screening.

Patients with a history of tuberculosis, or positive chest X-ray for tuberculosis, or positive PPD skin test result (defined as an induration of =5 mm) can not be enrolled in the study. Patients with a history of BCG vaccination having a positive PPD skin test, but no clinical or radiographic evidence of TB (confirmed by a radiologist) may be enrolled. Patient for which latent TB can not be ruled out are ONLY eligible for study entry if they are prophilactically treat with isoniazid initiated at least 1 month prior to re-screening and agree to maintain isoniazid therapy for six months.

Patients with a previous history of blood dyscrasias are excluded from study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified