Real Life Evaluation of Rheumatoid Arthritis Patients in Israel Treated With HUMIRA

Study Overview
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Brief Summary
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In Israel, data is lacking regarding the long-term effectiveness of Adalimumab in outpatient real life setting. Moreover, the association between long-term effectiveness of Adalimumab and patients' functional status as well as cultural aspects of sick leaves and visits to physician's clinics has not been demonstrated in this population. This study will collect the required data in real life settings.

Official Title
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Real Life Evaluation of Rheumatoid Arthritis Patients in Israel Treated With HUMIRA

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is eligible to Adalimumab treatment according to the Israeli National Health Basket and for whom a decision of initiating Adalimumab has already been taken. Patients that are naïve to Adalimumab therapy, that have been prescribed adalimumab in accordance to physician's clinical decision and according to local guidelines, up to 30 days prior to screening. Patient has performed tuberculosis (TB) screening and treatment according to national guidelines for TB screening prior to anti Tumor Necrosis Factor (anti-TNF) treatment. Patient has been diagnosed with Rheumatoid Arthritis (RA) and has disease duration < 3 years. Patient has moderately to severely active RA defined by Disease Activity Score (DAS) (moderately (3.2 ≤ DAS ≤ 5.1) severely (DAS ≥5.1)) Patient is able to sign written informed consent. Patient is treated with Methotrexate (MTX) alone or in combination with other Disease Modifying Antirheumatic Drugs (DMARDs) Patient might have been treated with another anti-TNF inhibitor agent if discontinued due to secondary loss of efficacy or side effects. Exclusion Criteria: Patient with known hypersensitivity to Adalimumab, or any of its components. Patients suffering from serious infection, latent TB or other conditions prohibiting the use of Adalimumab. Patient had previous non-response to an anti-TNF agent. Patients currently treated with other biologic therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderately to severely active RA patients<br>Moderately to severely active RA patients aged 18 years or older, both male and female | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who reached clinical response at 6 months | Proportion of patients who reached Disease Activity Score (DAS)-28 of less than 2.6 or a good DAS response compared to the score on Day 0. | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who reached clinical response at 24 months | Proportion of patients who reached Disease Activity Score (DAS)-28 of less than 2.6 or a good DAS response compared to the score on Day 0. | At 24 months | 
| Change in patient's functional status | Proportion of patients reaching HAQ <= 0.5 | Up to 24 months | 
| Change in frequency of sick leave episodes | Change in frequency of sick leave episodes | Up to 24 months | 
| Change in frequency of outpatient clinic visits | Change in frequency of outpatient clinic visits | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adalimumab, real life, RA, Humira, Rheumatoid Arthritis, effectiveness