Clinical trial NCT02322723: Real Life Evaluation of Rheumatoid Arthritis Patients in Israel Treated With HUMIRA
Official title: Real Life Evaluation of Rheumatoid Arthritis Patients in Israel Treated With HUMIRA
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rheumatoid Arthritis
Keywords: Adalimumab
real life
RA
Humira
Rheumatoid Arthritis
effectiveness
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: moderately to severely active Rheumatoid Arthritis patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients who reached clinical response at 6 months
timeFrame: At 6 months
Secondary outcomes:
measure: Proportion of patients who reached clinical response at 24 months
timeFrame: At 24 months
measure: Change in patient's functional status
timeFrame: Up to 24 months
measure: Change in frequency of sick leave episodes
timeFrame: Up to 24 months
measure: Change in frequency of outpatient clinic visits
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Dina Meyuhas, PhD
role: STUDY_CHAIR
References: