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

NCT ID: NCT02322723

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-02-29

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Moderately to severely active RA patients

Moderately to severely active RA patients aged 18 years or older, both male and female

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dina Meyuhas, PhD

Role: STUDY_CHAIR

AbbVie

Related Links

http://rxabbvie.com/

Related Info

Other Identifiers

P13-987

Identifier Type: -

Identifier Source: org_study_id