E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
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 test whether ARA290 reduces 1) diseae activity, 2) disability and 3) systemic inflammation in patients with active RA. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Diagnosis of RA, classified by ARA (American Rheumatism Association) 1987 revised criteria. 2) Active disease at screening and baseline: 6/68 tender and 6/66 swollen joints and either an erythrocyte sedimentation rate (ESR) of >=28 mm/hr or C-reactive protein (CRP)> 10 mg/l 3) Written informed consent
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E.4 | Principal exclusion criteria |
1) Current or previous treatment with biological agent 2) Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to rheumatoid arthritis (as judged by the investigator) 3) Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception 4) Participation in an investigational drug trial, current or in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year 5) Use of erythropoietin 6) Inability to follow the protocol and to comply with the follow up requirements 7) Clinically relevant abnormal history of physical and mental health other than conditions related to rheumatoid arthritis, as determined by medical history taking (as judged by the investigator) or any other condition that in the opinion of the investigator would complicate or compromise the well being of the subject.
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability parameters: 1) General safety measurements 2) 12-lead ECG 3) Blood Hematology 4) Blood Biochemistry 5) Adverse Event monitoring Efficacy parameters: 1) Circulating inflammatory markers (CRP, TNF, IL-1, IL-6, IL10) 2) Disabilty (measured with the Health assessment questionnaire disability index) 3) Disease Activity (measured with the Disease Activity Score: composite index including number of swollen and tender joints, patient's assessment of global health on a visual analogue scale and ESR)
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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 | Yes |
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 | Yes |
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) | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |