| 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 | Classification code | 10039073 | |
| 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 efficacy of 2 dose regimens of CDP870 in combination with methotrexate compared to methotrexate alone in:
1. The treatment of signs and symptoms in patients with active rheumatoid arthritis (RA).
2. The prevention of structural damage in patients with RA. | |
| E.2.2 | Secondary objectives of the trial | To assess the 2 dose regimens of CDP870 in combination with MTX compared to MTX
alone in:
1. The safety and tolerability in patients with active RA.
2. Improving physical function in patients with active RA.
3. Achieving a major clinical response in patients with active RA.
4. Health Outcome Measures in patients with active RA.
5. Assessing the pharmacokinetic profile and immunogenicity of 2 dose regimens of
CDP870 in combination with methotrexate. | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | A diagnosis of adult-onset RA (of at least six months duration but not longer then 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria.
Active RA disease at Screening and Baseline as defined as ≥9 tenderjoints, ≥9 swollen joints and fulfilling one of the following two criteria, namely, ≥30mm/hour ESR (Westergren) or CRP> 15 mg/L.
Must have received a stable dose of methotrexate with or without folic acid for at least 3 months prior to Baseline visit. The minimum dose is 10 mg methotrexate weekly. No other DMARD is permitted. | |
| E.4 | Principal exclusion criteria | A diagnosis of any other inflammatory arthritis e.g. psoriatic arthritis or ankylosing spondylitis.
A secondary, non-inflammatory type arthritis (e.g. OA or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of RA.
Does not meet any of the concomitant medication criteria (see protocol, section 3.3.2).
A history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or any current sign or symptom that my indicate an infection (e.g. fever, cough).
A history of tuberculosis or positive chest X-ray for tuberculosis or positive (defined as positive induration per local medical practice) PPD skin test. Patients with a positive PPD skin test who have received a BCG vaccination and have a negative chest X-ray for tuberculosis (TB) may be enrolled.
A history of an adverse reaction to PEG or a protein medicinal product. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | ACR20 responder rate at week 24.
Change from baseline in Modified Total Sharp Score at week 52. | |
| 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 | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | Yes |
| 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 | 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 | When the last patient completes 12 week follow-up visit (after week 52 visit) or is enrolled into follow-on study, CDP870-028 (at week 52).
If not, premature termination of the trial is described in section 6 of the protocol.
| |
| 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 | 3 |
| 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 | 3 |
