Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions
NCT03073109
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Bordeaux,
- Limoges,
- Birmingham, Alabama
- Montpellier,
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title | Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions | ||||
Official Title | PATIENT-REPORTED OUTCOMES IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB OR BIOLOGICAL DISEASE-MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN REAL LIFE CONDITIONS | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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 | ||||
Condition | Arthritis, Rheumatoid | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment | 170 | ||||
Original Estimated Enrollment | 320 | ||||
Actual Study Completion Date | September 16, 2019 | ||||
Actual Primary Completion Date | September 16, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender |
| ||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Colombia, Peru | ||||
Removed Location Countries | Ecuador | ||||
Administrative Information | |||||
NCT Number | NCT03073109 | ||||
Other Study ID Numbers | A3921284 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | October 2020 |