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 | 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 | 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 | LLT |
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 | Information not present in EudraCT |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Randomized, controlled, double blind multi-center trial, main purpose is toa ssess whether a 6 months treatment adalimumab added on a conventional DMARD therapy will decrease the number of days on sick leave compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
The cost-effectiveness and cost utility of the intervention compared to the conventional tretament. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) A diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria 2) RA duration of < 2 years 3) Age 25-55 years 4) Active RA with at least 3 active joints (tender and/or swollen joints) 5) Stable DMARD combination treatment for more than 3 months 6) At least one of the following Rheumatoid factor positive One or more erosions in x-rays of the hands and feet Anti-citrulline antibodies positive 7) At least other of the following HAQ-index 0.5 or more Patient or physician evaluation of RA activity >25 mm (VAS 10 cm) 8) Patient has been steadily in work-life for at least one year and is currently working or on sick-leave but not applying for pension 9) Patient feels that he/she will likely have to be off-work during the following 6 months due to his/her RA 10) Patient must be willing and able to provide written informed consent for the trial
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E.4 | Principal exclusion criteria |
1) A subject must not have a history of biological drug use for RA 2) A subject must not have evidence of active or latent tuberculosis, 3) A subject must not have any history of lymphoproliferative disease or malignancy within the previous 5 years 4) A subject must not have any other condition, that according to the investigator’s judgment makes him or her non-eligible for anti-TNF use 5) A subject must not have no inflammatory rheumatic disease other than RA 6) A subject must not have received any other investigational agents within 30 days prior to baseline visit, and must not receive them during the current trial 7) A female subject must not be pregnant or breast-feeding or planning pregnancy during the following year 8) A subject must not have had a major surgery within one month prior to study entry and must not have a scheduled operation during the 6-month follow up 9) A subject must not have any clinically significant condition or situation, other than the condition being studied, that in the opinion of the investigator would interfere with the optimal participation in the trial. 10) A subject must not fulfill the criteria for reimbursement for biologics for RA and he/she would not normally be prescribed a biological drug according to physicians discretion and national treatment guidelines
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of lost work days due to RA during the 6-month 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 | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 14 |
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 | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |