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Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions

Last updated on May 7, 2019

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Study Location
Artmedica
Medellin, Antioquia, Colombia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Patients ≥ 18 years of age at the time of recruitment

- Patient diagnosed with moderate to severe RA ≥ 6 months before enrollment

- Patients who have had an inadequate response to the continuous use of methotrexate or
combination of conventional DMARDs for at least 12 weeks before the study without dose
change within the last 8 weeks before enrollment in the study

- Patients with no biological DMARDs use in patient history.

- Patients prescribed with tofacitinib or biological DMARDs in the last two weeks at
doses established in ACR guidelines published in 2015 and following medical criteria.

- Acceptance for patients to participate in the study and signing of the informed
consent.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Patients who do not have the ability to answer the questionnaires by themselves or who
have any kind of mental disorder that may affect their answers.

- Patients diagnosed with autoimmune rheumatic diseases other than RA and Sjogren's
syndrome.

- Patients treated with biological DMARDs in monotherapy.

- Participation in other studies involving investigational drug(s) (Phases 1-4) within 4
weeks or 5 half-lives (whichever is longer) after discontinuation of the
investigational compound before the current study begins and/or during study
participation.

- Patients with any current malignancy or a history of malignancy, with the exception of
adequately treated or excised non-metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.

- Patients with lymphoproliferative disorders (e.g., Epstein Barr Virus (EBV) related
lymphoproliferative disorder), a history of lymphoma, leukemia, or signs and symptoms
suggestive of current lymphatic disease.

NCT03073109
Pfizer
Recruiting
Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions

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