Rheumatoid Arthritis
Conditions
Keywords
Adalimumab, real life, RA, Humira, Rheumatoid Arthritis, effectiveness
Brief summary
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Patient has performed tuberculosis (TB) screening and treatment according to national guidelines for TB screening prior to anti Tumor Necrosis Factor (anti-TNF) treatment. 3. Patient has been diagnosed with Rheumatoid Arthritis (RA) and has disease duration \< 3 years. 4. Patient has moderately to severely active RA defined by Disease Activity Score (DAS) (moderately (3.2 ≤ DAS ≤ 5.1) severely (DAS ≥5.1)) 5. Patient is able to sign written informed consent. 6. Patient is treated with Methotrexate (MTX) alone or in combination with other Disease Modifying Antirheumatic Drugs (DMARDs) 7. Patient might have been treated with another anti-TNF inhibitor agent if discontinued due to secondary loss of efficacy or side effects.
Exclusion criteria
1. Patient with known hypersensitivity to Adalimumab, or any of its components. 2. Patients suffering from serious infection, latent TB or other conditions prohibiting the use of Adalimumab. 3. Patient had previous non-response to an anti-TNF agent. 4. Patients currently treated with other biologic therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who reached clinical response at 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who reached clinical response at 24 months | 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. |
| Change in patient's functional status | Up to 24 months | Proportion of patients reaching HAQ \<= 0.5 |
| Change in frequency of sick leave episodes | Up to 24 months | Change in frequency of sick leave episodes |
| Change in frequency of outpatient clinic visits | Up to 24 months | Change in frequency of outpatient clinic visits |
Outcome results
None listed