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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03073109
• Date of registration: 03/01/2017
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions
• Scientific title: PATIENT-REPORTED OUTCOMES IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB OR BIOLOGICAL DISEASE-MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN REAL LIFE CONDITIONS
• Date of first enrolment: March 15, 2017
• Target sample size: 170
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03073109
• Study type: Observational

Countries of recruitment

Colombia, Ecuador, Peru

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Primary Outcome(s)

Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6 [Time Frame: Baseline, Month 6]

Secondary Outcome(s)

Number of Participants Who Withdrew From Study Due to Adverse Events And Due to All Causes [Time Frame: Baseline up to Month 6]

Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 [Time Frame: Month 6]

European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6 [Time Frame: Month 6]

Change From Baseline in European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6 [Time Frame: Baseline, Month 6]

Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6 [Time Frame: Baseline, Month 6]

Number of Participants With Serious Adverse Event (SAE) and Non-serious Adverse Events (AEs) [Time Frame: Baseline up to Month 6]

Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6 [Time Frame: Month 6]

Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 [Time Frame: Month 6]

Change From Baseline in Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 [Time Frame: Baseline, Month 6]

Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 [Time Frame: Baseline, Month 6]

Number of Participants With Serious Infections [Time Frame: Baseline up to Month 6]

Secondary ID(s)

A3921284

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03073109