E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
CP-690,550 is being developed for the treatment of patients with moderate-to-severe Crohns disease, as defined by a baseline Crohns Disease Activity Index (CDAI) score of 220 to 450 inclusive. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to demonstrate efficacy of CP-690,550 in inducing a clinical response in subjects with moderate-to-severe Crohns disease. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the safety and tolerability of oral CP-690,550 in subjects with active Crohns 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 Crohns disease. 3. To characterize the pharmacokinetics of CP-690,550 in subjects with active Crohns disease. 4. To evaluate the effect of treatment of CP-690,550 on Quality Of Life in subjects with active Crohns disease. 5. To demonstrate the change from baseline in following biomarkers: CRP, fecal calprotectin. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOGENETICA: Versione:finale Data:2007/08/13 Titolo:MOLECULAR PROFILING SUPPLEMENT SAMPLES FOR PFIZERS EXPLORATORY RESEARCH BIOBANK Obiettivi:
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E.3 | Principal inclusion criteria |
1. Subjects must be at least 18 years of age. 2. Males and females with clinical evidence of Crohns disease for at least 3 months duration and moderate-to-severe disease at baseline, as defined by a Crohns 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 Crohns disease. 4. Subjects currently receiving the following treatment regimens for Crohns 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 as listed in Section 4.4.5.4. 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. |
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E.4 | Principal exclusion criteria |
1. Diagnosis of indeterminate colitis, Ulcerative Colitis (UC), or clinical findings suggestive of UC. 2. Treatment naïve subjects diagnosed with Crohns Disease (without previous exposure to treatment) 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-TNFα 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 (>100 cm) 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 (such as EBV-related lymphoproliferative disorder, as reported in some subjects on other immunosuppressive drugs), 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 (PPD) 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical response (Week 4) defined by a decrease in the Crohns disease activity index (CDAI) score (Appendix 1) of at least 70 points from baseline. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tollerabilita', Qualita' della vita |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |