E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 establish whether patients with primary OA confined to the knee with symptomatic disease experience pain-relief during treatment with 40 mg adalimumab (Humira) sc. every other week for 12-weeks
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E.2.2 | Secondary objectives of the trial |
- Changes at week 2, 6, 18 and 24 in WOMAC-pain score from baseline - Changes at week 2, 6, 12, 18, and 24 in other WOMAC scores from baseline - Changes at week 12 and 24 in quality of life (SF-36) from baseline - Changes in concomittant medication |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Above 50 years of age - Body mass index < 35 kg/m2 - Diagnose of primary osteoarthritis in the femero-tibiale region and in accordance with ACR combined clinical and radiographic criteria - WOMAC-pain score > 40 mm despite treatment with NSAID and/or paracetamol - Able and willing to give written informed consent and to comply with the requirements of the study protocol |
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E.4 | Principal exclusion criteria |
- Positive serology for hepatitis B or C indicating active infection - History of positive HIV status - History of tuberculosis, histoplasmosis or listeriosis - Subjects with latent TB (positive PPD skin test and/or chest X-ray indicative for TB) or having other risk factors for activation of latent TB must have TB prophylaxis starting four weeks prior to the first administration of study drug in accordance with local recommendations - Persistent or recurrent infections or severe infections requiring hospitalisation or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrolment - History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma or cervical dysplasia - Co morbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III-IV), active inflammatory bowel disease, recent stroke (within three months), chronic leg ulcer and any other condition (e.g. indwelling urinary catheter) which, in the opinion of the investigator, would put the subject at risk by participation in the protocol - Female subjects who are pregnant or breast –feeding - Previous diagnosis or signs of central nervous system demyelinating diseases (e.g. optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia)
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end points: - Changes at week 12 in WOMAC-pain score from baseline - Safety during 12 weeks treatment and 12 weeks follow-up |
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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 | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Information not present in EudraCT |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 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
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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 | 4 |
E.8.9.1 | In the Member State concerned days | |