E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to severely active Ulcerative Colitis |
|
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 | 10009900 |
E.1.2 | Term | Colitis ulcerative |
|
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 |
Assessment of the efficacy and the safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Male and female 18 years of age. 2.Diagnosis of UC for greater than 3 months. 3.Diagnosis of UC confirmed by screening endoscopy with exclusion of infectious cause. 4.Active UC with a Mayo Clinic score of 6 to 12 points and endoscopic subscore of 2-3 despite concurrent treatment with oral corticosteroids, and/or azathioprine or 6-mercaptopurine 6-MP 5.Subject is judged to be in generally good health by the investigator. 6.Subject must be able and willing to self-administer SC injections or has available qualified person s to administer SC injections. 7.Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol. 8.If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile bilateral tubal ligation, bilateral oophorectomy or hysterectomy , or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion Condoms, sponge, foams, jellies, diaphragm or intrauterine device IUD contraceptives oral or parenteral for 3 months prior to study drug administration A vasectomized partner 9.If female of child bearing potential, the results of serum pregnancy test performed at Screening and urine pregnancy test at Baseline visit are negative. |
|
E.4 | Principal exclusion criteria |
1.Previous treatment with infliximab or other anti-TNF agent. 2.History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for ulcerative colitis or is planning bowel surgery. 3.Received cyclosporine, tacrolimus, mycophenolate mofetil, or methotrexate within 8 weeks prior to Baseline. 4.Received intravenous corticosteroid within 2 weeks prior to Screening. 5.Received therapeutic enema other than required for endoscopy within 2 weeks prior to Screening. 6.Fulminent colitis and/or toxic megacolon. 7.Currently receiving total parenteral nutrition TPN . 8.Indeterminate colitis or Crohn s disease on Screening biopsy, or clinical or biopsy findings suggestive of Crohn s disease. 9.Discontinued use of azathioprine or 6-MP, aminosalicylates, or UC-related antibiotics within 4 weeks of Baseline or has discontinued use of corticosteroid within 2 weeks of Baseline. 10.For subjects using aminosalicylates, use of the medication for less than 12 weeks prior to Baseline or has not been on stable dose for at least 4 weeks prior to Baseline. 11.For subject using UC related antibiotics, has not been on stable doses of these medications for at least 4 weeks prior to Baseline. 12.For subjects using probiotics, has not stopped these medications at Screening. 13.Persistent chronic or active non-UC related infections requiring treatment with intravenous iv antibiotics, iv antivirals, or iv antifungals within 30 days or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline. 14.History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix. 15.Immuno-compromised conditions or history of HIV. Subject with a history of listeria, hepatitis B infection, or human immunodeficiency virus HIV or a history of previously untreated tuberculosis. 16.History of listeriosis, history of histoplasmosis, or active TB. 17.History of neurologic symptoms suggestive of central nervous system CNS demyelinating disease. 18.Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.There should be at least a 150-day period between the last dose of study drug and either conception or initiation of breast-feeding in women of childbearing potential. 19.Poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol. 20.Received investigational biological or chemical agents within 30 days or 5 half-lives prior to Screening whichever is longer . 21.Subject with a history of clinically significant drug or alcohol abuse during the past year. 22.Known history of allergic reaction or significant hypersensitivity to the constituents of adalimumab |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with remission at week 8 |
|
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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
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 | 11 |
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 | 16 |