E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Enthesitis Related Arthritis (ERA) |
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E.1.1.1 | Medical condition in easily understood language |
Arthritis is a joint disorder which involves in inflammation of one or more joints. Enthesitis is when swelling or inflammation occurs where tendons or ligaments attach to bone. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003246 |
E.1.2 | Term | Arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 |
The objectives of this study are to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA), and to examine the pharmacokinetics and immunogenicity of adalimumab following SC administration in this subject population. |
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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 |
1. Age 6 through 17 years
2. Diagnosis of ERA as defined by ILAR
3. Disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location
4. Inadequate response or intolerance to at least one nonsteroidal anti-nflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate. |
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E.4 | Principal exclusion criteria |
1. Any ILAR JIA subtype other than ERA
2. Psoriasis or a history of psoriasis in the patient or first-degree relative
3. Presence of IgM rheumatoid factor
4. Presence of systemic JIA, history of inflammatory bowel disease, previous biologic therpay including anti-TNF therapy with a potential impact on pediatric ERA
5. Infection(s) requiring treatment with IV anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent change in the number of active joints with arthritis |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. The presence or absence of enthesitis at 35 different anatomical locations
2. The presence or absence of joint tenderness at 72 joints
3. The presence or absence of joint swelling at 68 joints
4. 30, 50 and 70% improvement, respectively, in at least three of the six JRA core set criteria, with 30% worsening in no more than one of the six JRA core set criteria. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
Canada |
Czech Republic |
France |
Germany |
Italy |
Mexico |
Poland |
Spain |
Sweden |
Switzerland |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 4 |
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 |