E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
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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 |
To assess the clinical response rate as measured by American College of Rheumatology 20% (ACR20) response rate at Week 12 |
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E.2.2 | Secondary objectives of the trial |
To assess for all patients at Week 12: The clinical response rate as measured by American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) The reduction of disease activity by DAS28(CRP) [Disease Activity Score - 28 (C-reactive protein)], SDAI [Simplified Disease Activity Index] and CDAI [Clinical Disease Activity Index] (1,2) The achievement of clinical remission (by DAS28(CRP), SDAI and CDAI) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients must be at least 18 years old at the screening visit. 2. Patients must be able to understand the information provided to them and to give written Informed Consent. 3. Female patients must be either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence only is not an acceptable method. Patients must agree to use adequate contraception during the study and for 12 weeks after their last dose of CZP. Male patients must agree to ensure they or their female partner(s) uses adequate contraception during the study and for 12 weeks after the patient receives their last dose of CZP. 4. Patients must have a diagnosis of adultonset RA of at least three months duration as defined by the 1987 ACR classification criteria. |
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E.4 | Principal exclusion criteria |
1. Patients have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis). 2. Patients have >3 arthroplasties due to RA and/or Steinbrocker IV functional capacity. 3. Patients have a secondary, noninflammatory type of arthritis (e.g., osteoarthritis or fibromyalgia) that in the Investigators opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the patients primary diagnosis of RA. 4. Patients have a history of an infected joint prosthesis at any time with that prosthesis still in situ. 5. Patients have received any experimental nonbiological therapy, within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline visit (whichever is longer). 6. Patients have received any experimental biological agent within or outside of a clinical study in the past three months or within 5 half-lives prior to Baseline (whichever is longer). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the ACR 20 (American College of Rheumatology 20% response criteria) responder rate at Week 12. |
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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 | No |
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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
la seconda parte del disegno dello studio e` in aperto |
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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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |