CROHN’S DISEASE MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Conditions
Interventions
Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540-737-29-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo:
Sponsors
Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be at least 18 years of age. 2. Males and females with clinical evidence of Crohn’s disease for at least 3 months duration and moderate-to-severe disease at baseline, as defined by a Crohn’s Disease Activity Index (CDAI) score of 220 to 450 inclusive. 3. Visualization of the GI tract (radiology, scintigraphy or endoscopy) within 24 months prior to screening to confirm diagnosis and extent of Crohn’s disease. 4. Subjects currently receiving the following treatment regimens for Crohn’s Disease are eligible providing they are on stable dose for designated period of time: • 5-ASA or sulfasalazine stable dose for at least 3 weeks prior to baseline and during the study treatment period. • Corticosteroids (prednisolone 30 mg or less or equivalent, budesonide 9 mg/kg or less) stable dose for at least 2 weeks prior to baseline. • Antibiotics (eg metronidazole, rifaximin) stable dose for at least 2 weeks prior to baseline and during the study treatment period. • Rectally administered formulation of corticosteroids or 5-ASA stable dose for at least 2 weeks prior to baseline and during the study treatment period. 5. Subjects willing to use double contraception during the study treatment period and until completion of follow-up procedures: • If the subject is a sexually active woman of childbearing potential, she and her male partner are required to simultaneously use 2 effective contraceptive methods as listed in Section 4.4.5.2 Female subjects who wish to use non-hormonal contraception must have done so for at least 14 days prior to the first dose of study medication. • Non-vasectomized males with female partners of child bearing potential must be willing to use a condom in addition to having their female partner use another form of contraception. 6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 7. Evidence of a signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study. 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: 1. Diagnosis of indeterminate colitis, Ulcerative Colitis (UC), or clinical findings suggestive of UC. 2. Treatment naïve subjects diagnosed with Crohn’s Disease 3. Subjects receiving the following therapy: • Azathioprine/6-Mercaptopurine, Methotrexate within 7 days prior to baseline. • Cyclosporine, Mycophenolate, Tacrolimus within 4 weeks prior to baseline. • Interferon therapy within 8 weeks prior to baseline. • Anti-TNFa therapy within 8 weeks prior to baseline. 4. Subjects who are currently receiving natalizumab. 5. Subjects who have previously participated in any study of CP-690,550. 6. Subjects who have received any investigational drug or device within 3 months prior to baseline. 7. History of symptomatic obstructive strictures, an ostomy, extensive bowel resection or short bowel syndrome 8. History of bowel surgery within 6 months prior to baseline 9. Fecal culture indicating presence of pathogenic infection 10. Subjects likely to require any type of surgery within 8 weeks from screening 11. Known collection or abscess on MRI of the pelvis 12. Subjects on elemental diet used for treating Crohn's disease within 7 days from baseline 13. Subjects with evidence of hematopoietic disorders: • Hemoglobin levels <9.0 g/dL or hematocrit <30% at screening visit or within the 3 months prior to baseline • An absolute white blood cell (WBC) count of <3.0 x 109/L (<3000/mm3) or absolute neutrophil count of <1.2 X 109/L (<1200/mm3) at screening visit or within the 3 months prior to baseline • Thrombocytopenia, as defined by a platelet count <100 x 109/L (<100,000/mm3) at screening visit or within the 3 months prior to baseline 14. Total bilirubin, AST or ALT more than 2 times the upper limit of normal at screening visit 15. Estimated GFR =50 ml/min based on Cockcroft-Gault calculation 16. Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease 17. Current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 8 weeks of baseline 18. Current routine household contact with children who have received varicella or oral polio vaccine within 2 months prior to baseline or scheduled to receive vaccination during study treatment and follow up period 19. History of any lymphoproliferative disorder, history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease 20. Evidence of active or latent infection with Mycobacterium tuberculosis (TB), as defined by any of the following: • A subject has a positive Mantoux Purified Protein Derivative skin test result of =5 mm of induration within the 3 months prior to screening. • A subject is immunoreactive for TB using an ex vivo method (eg QuantiFERON-TB Gold (QFT Gold) or T-Spot test). • A subject has a chest radiograph (taken within the 3 months prior to screening) that has changes suggestive of active TB infection. 21. Subjects with clinically significant infections currently or within 6 months of baseline (eg those requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections), or those with a history of more than one episode of herpes zoster, a history of disseminated zoster, a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study or any infection requiring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate efficacy of CP-690,550 in inducing a clinical response in subjects with moderate-to-severe Crohn’s disease.;Secondary Objective: The secondary objectives are: 1. To evaluate the safety and tolerability of oral CP-690,550 in subjects with active Crohn’s disease. 2. To further evaluate the efficacy of CP-690,550 in inducing clinical remission and to characterize the time to response and remission in subjects with active Crohn’s disease. 3. To characterize the pharmacokinetics of CP-690,550 in subjects with active Crohn’s disease. 4. To evaluate the effect of treatment of CP-690,550 on Quality Of Life in subjects with active Crohn’s disease. 5. To demonstrate the change from baseline in following biomarkers: CRP, fecal calprotectin.;Primary end point(s): Clinical response (Week 4) defined by a decrease in the Crohn’s disease activity index (CDAI) score of at least 70 points from baseline. | — |
Countries
Belgium, Czech Republic, France, Hungary, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed