E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The trial aims to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 main objective of the trial is to continue to assess safety of certolizumab pegol as per adverse events reporting |
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E.2.2 | Secondary objectives of the trial |
To describe the evolution of long term efficacy (through maintenance of clinical remission) in Crohn’s disease patients who have completed COSPAR I trial (C87059)·To assess the effect of induction/treatment with certolizumab pegol in patients who have failed to maintain clinical remission off steroids in COSPAR I trial (C87059) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients on placebo and/or active drug who were unable to complete corticosteroid tapering or who needed to be restarted on corticosteroids, and patients suffering from Crohn's disease who have successfully completed, in remission, the C87059 trial. Patients able to understand the information provided to them and who have given written informed consent for C87065. If female, the patient is either postmenopausal for atleast one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception( oral or parenteral hormonal contraceptive; intrauterine device; barrier or spermicide-abstinence is not an acceptable method. Patients must agree to use adequate contraception during the trial and for 12 weeks after the last dose of certolizumab. If the patient is on immunosuppresant ( azathioprine, 6-mercaptopurine and methotrexate) are allowed immunosuppresants, the dose has to have been stable during the 8 weeks preceding and throughout the C87059 trial and is expected to remain stable during the extension trial. If the patient is on a 5-ASA analogue for Crohn's disease, the dose has to have been stable during, and for the 4 weeks preceding, the C87059 trial and is expected to remain stable during the extension trial. |
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E.4 | Principal exclusion criteria |
Subjects withdrawn or discontinued from the C87059 trial for reasons other than those listed in Inclusion 1. Subject who received treatment other than trial medication and other than medications permitted in the C87059 trial. Subjects from countries where certolizumab pegol is authorised in Crohn's disease treatment. Patients who have developed medical conditions excluded in the C87059 trial will be excluded from participation in C87065. Patients who took permitted antibiotics for conditions other than Crohn's disease in C87059 will be allowed to enter trial C87065 as long as the antibiotic use has not occured within two weeks of entry into C87065. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable will be the proportion of patients who completed COSPAR I and have remained off corticosteroids and in disease remission (CDAI <=150). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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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Patients will be treated until certolizumab pegol is available commercially for Crohn's disease indication in their respective countries |
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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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |