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

NCT02322723 | Withdrawn

• 1 other identifier: P13-987
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Adalimumab; real life; RA; Humira; Rheumatoid Arthritis; effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of patients who reached clinical response at 24 months

  At 24 months

• Change in patient's functional status

  Up to 24 months

• Change in frequency of sick leave episodes

  Up to 24 months

• Change in frequency of outpatient clinic visits

  Up to 24 months

Study Arms (1)

Moderately to severely active RA patients

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

moderately to severely active Rheumatoid Arthritis patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dina Meyuhas, PhD

  AbbVie

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 23, 2014
• Study Start: February 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 19, 2016

Record last verified: 2016-02