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

Rheumatoid Arthritis Clinical Trial

— ORIENT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02322723
• Other study ID #: P13-987
• Status: Withdrawn
• Phase: N/A
• First received: December 19, 2014
• Last updated: February 17, 2016
• Start date: February 2016
• Est. completion date: February 2020

Study information

• Verified date: February 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change in patient's functional status	Proportion of patients reaching HAQ <= 0.5	Up to 24 months	No
Secondary	Change in frequency of sick leave episodes	Change in frequency of sick leave episodes	Up to 24 months	No
Secondary	Change in frequency of outpatient clinic visits	Change in frequency of outpatient clinic visits	Up to 24 months	No

External Links

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