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

NCT03073109 | Completed Results

• 1 other identifier: A3921284
• Study Type: observational
• Target: 170
• Locations: 2 countries
• Sites: 13

Brief Summary

This study is aimed to describe the outcomes related to physical activity, activity of disease, quality of life, work productivity and safety in Latin-American patients with Rheumatoid Arthritis (RA) treated with tofacitinib or biological DMARDs after failure to respond to conventional DMARDs in real-life conditions. This will be a non-interventional, hybrid study (prospective and retrospective data collection) comparing tofacitinib to biologic DMARD treatments in patients with RA after failure of conventional DMARDs. The population will be composed by adult patients over 18 years of age diagnosed with RA and who have been prescribed tofacitinib or any biological DMARDs.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6

  Disease activity was assessed using RAPID3, which was based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and patient global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give a total score=0 to 10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain/feeling very well to '10'=pain as bad as it could be/ feeling very poorly, higher scores=greater difficulty/ worsening of condition. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).

  Baseline, Month 6

Secondary Outcomes (11)

• Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6

  Month 6

• Change From Baseline in Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6

  Baseline, Month 6

• European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6

  Month 6

• Change From Baseline in European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6

  Baseline, Month 6

• Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6

  Month 6

Eligibility Criteria

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

Study Population

Adult patients ≥ 18 years of age diagnosed with RA and who failed to respond to conventional DMARDs, and have been prescribed tofacitinib or any biological DMARDs

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (13)

Artmedica

Medellín, Antioquia, Colombia

Location

Fundacion Instituto de Reumatologia Fernando Chalem

Bogota, Cundinamarca, Colombia

Location

IDEARG

Bogota, Cundinamarca, Colombia

Location

Clinica de Occidente

Cali, Valle del Cauca Department, Colombia

Location

Centro Integral de Reumatología del Caribe Circaribe S.A

Barranquilla, Colombia

Location

Clinicos IPS

Bogotá, 111211, Colombia

Location

Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM

Bogotá, Colombia

Location

SERVIMED

Bucaramanga, Colombia

Location

Fundacion Valle del Lili

Cali, Colombia

Location

REUMALAB

Medellín, Colombia

Location

Clínica San Judas Tadeo

Lima, SAN Miguel, 15086, Peru

Location

Centro Medico CEEN

Arequipa, Peru

Location

Clinica Jockey Salud

Lima, Peru

Location

Related Publications (2)

• Reyes JM, Gutierrez MV, Madariaga H, Otero W, Guzman R, Izquierdo J, Abello M, Velez P, Castillo D, Ponce de Leon D, Lukic T, Amador L. Patient-reported outcomes in RA patients treated with tofacitinib or bDMARDs in real-life conditions in two Latin American countries. Reumatol Clin (Engl Ed). 2023 Jun-Jul;19(6):319-327. doi: 10.1016/j.reumae.2023.02.006.

  PMID: 37286268 DERIVED

• Gutierrez-Ardila MV, Reyes J, Madariaga H, Otero W, Guzman R, Izquierdo J, Abello M, Velez P, Castillo D, Ponce de Leon D, Lukic T, Amador L. Work productivity in rheumatoid arthritis patients from two Latin American countries treated with tofacitinib or biological DMARDs. Expert Rev Pharmacoecon Outcomes Res. 2022 Jul;22(5):787-794. doi: 10.1080/14737167.2022.2047935. Epub 2022 Mar 16.

  PMID: 35249439 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

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

Limitations and Caveats

DAS 28 data for month 3 was not collected and analyzed since data was planned to be collected depending on the availability of medical records as specified in analysis.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: March 8, 2017
• Study Start: March 15, 2017
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (10); PE (3)