E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Erosive interphalangeal osteoarthritis |
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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 investigate the efficacy of a treatment with adalimumab 40 mg sc every other week as therapeutic intervention in erosive interphalangeal osteoarthritis |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Males and females > or = 18 years of age. • Subjects with hand OA showing or having suffered from transient inflammatory attacks of the interphalangeal finger joints characteristic for what has been termed ‘inflammatory’ or ‘erosive’ hand OA. • Subjects with hand OA in which at least 1 interphalangeal finger joint has the typical appearance on the roentgenpicture of an ‘E’ phase joint as defined by the criteria mentioned above. • Able and willing to self-administer sc injections or have available a suitable person to administer sc injections • 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 |
• Prior treatment with any investigational agent within 30 days, or five half lives of the product, whichever is longer. • Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid arthritis, spondylarthropathy, Psoriatic arthritis, gout, chondrocalcinosis or other auto-immune diseases • Prior use of any chondroprotective drug within 90 days e.g.. chondroitin sulfate, glucosamine, avocado-soybean unsaponifiables, tetracyclins, corticosteroids. • Prior use of any immunomodulating drug with possible effects on proinflammatory cytokine metabolism within 90 days a.o. corticosteroids, methotrexate, sulfasalazine, leflunomide, D-Penicilamin, anti-malarials, cytotoxic drugs, TNF blocking agents • Patient who is pregnant; if the patient is of child-bearing age, he/she must use effective means of contraception during the study. • Patient who has a known blood coagulation disorder • History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia, with no recurrence within the last two years • Comorbidities: 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. • Positive serology for hepatitis B or C indicating active infection. • History of positive HIV status. • Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment. • Female subjects who are pregnant or breast-feeding. • History of clinically significant drug or alcohol abuse in the last year. • Previous diagnosis or signs of central nervous system demyelinating diseases (e.g., optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia). • Medical history of systemic lupus erythematosus • Evolutive tuberculosis or other severe infections like sepsis and opportunistic infections • Patients with latent TB (positive PPD skin and/or chest X-ray indicative for TB) or having other risk factors for activation of latent TB, e.g. previous exposure to TB, who have not initiated a TB prophylaxis prior to the first adalimumab treatment. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is the number of patients of whom all erosive joints start the remodeling process (‘R’ phase) during the first year. Remodeling is defined by the occurrence of 3 roentgenological features: -1- the sharper demarcation of the erosive lesions -2- new bone formation in the eroded subchondral plate – decrease in size of lesions -3- new bone formation at the joint margins – osteophyte formation |
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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 | No |
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 | 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) | 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 | 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 | No |
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
| 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
| |
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 | 6 |
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 | 6 |