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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 July 31, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Patient-Reported Outcomes In Rheumatoid Aarthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions
Patient-reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-modifying Antirheumatic Drugs (Dmards) In Real Life Conditions
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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
Arthritis, Rheumatoid
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
March 15, 2018
March 15, 2018   (Final data collection date for primary outcome measure)

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 newly prescribed with tofacitinib or biological DMARDs at doses established in ACR guidelines 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Colombia,   Ecuador,   Peru
 
 
NCT03073109
A3921284
No
Not Provided
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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