A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

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Pfizer

Status and phase

Completed
Phase 2

Conditions

Crohn's Disease

Treatments

Drug: Placebo
Drug: CP-690,550

Study type

Interventional

Funder types

Industry

Identifiers

NCT01393626
A3921083
2011-001733-16 (EudraCT Number)

Details and patient eligibility

About

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).

Enrollment

280 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands).
  • Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening.
  • Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.

Exclusion criteria

  • Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC.
  • Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve).

Subjects receiving the following treatment for Crohn's disease:

  • Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.
  • Anti-TNFα therapy within 8 weeks prior to baseline.
  • Interferon therapy within 8 weeks prior to baseline.
  • Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.
  • Intravenous corticosteroids within 2 weeks prior to baseline.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

280 participants in 3 patient groups, including a placebo group

Placebo BID
Placebo Comparator group
Treatment:
Drug: Placebo
5mg BID
Experimental group
Treatment:
Drug: CP-690,550
10mg BID
Experimental group
Treatment:
Drug: CP-690,550

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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