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

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.

Study Overview

• Status: Withdrawn
• Conditions: Rheumatoid Arthritis

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

moderately to severely active Rheumatoid Arthritis patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Chair: Dina Meyuhas, PhD, AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 17, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: effectiveness; Rheumatoid Arthritis; Adalimumab; RA; Humira; real life
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: P13-987