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

NCT03073109

Last updated date
Study Location
Artmedica
Medellin, Antioquia, , Colombia
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis, Rheumatoid
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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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

Arthritis, RheumatoidStudy of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate
NCT00628095
  1. Mesa, Arizona
  2. Debary, Florida
  3. Lake Mary, Florida
  4. Tampa, Florida
  5. Avon, Indiana
  6. New Orleans, Louisiana
  7. Frederick, Maryland
  8. Columbia, Missouri
  9. Columbia, Missouri
  10. Reno, Nevada
  11. Cincinnati, Ohio
  12. Spokane, Washington
  13. Providencia, Santiago, RM
  14. Ceska Lipa,
  15. Praha 2,
  16. Praha 4,
  17. Incheon,
  18. Pusan,
  19. Mexico, D.f.
  20. Krakow,
  21. Poznan,
  22. Poznan,
  23. Santiago de Compostela, A Coruña
  24. A Coruña,
  25. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Arthritis, RheumatoidEtanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)
NCT01230177
  1. Sendai, Miyagi
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Arthritis, RheumatoidStudy of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
NCT00960440
  1. Birmingham, Alabama
  2. Los Angeles, California
  3. Los Angeles, California
  4. San Diego, California
  5. Farmington, Connecticut
  6. Trumbull, Connecticut
  7. Aventura, Florida
  8. Tampa, Florida
  9. Atlanta, Georgia
  10. Boise, Idaho
  11. Idaho Falls, Idaho
  12. Springfield, Illinois
  13. Indianapolis, Indiana
  14. New Orleans, Louisiana
  15. Portland, Maine
  16. Cumberland, Maryland
  17. Worcester, Massachusetts
  18. Flowood, Mississippi
  19. Tupelo, Mississippi
  20. Lebanon, New Hampshire
  21. Voorhees, New Jersey
  22. Rocky Mount, North Carolina
  23. Bethlehem, Pennsylvania
  24. Willow Grove, Pennsylvania
  25. Wyomissing, Pennsylvania
  26. Hixson, Tennessee
  27. Knoxville, Tennessee
  28. Nashville, Tennessee
  29. Dallas, Texas
  30. Dallas, Texas
  31. Fort Worth, Texas
  32. Houston, Texas
  33. Lubbock, Texas
  34. Vancouver, Washington
  35. Vancouver, Washington
  36. Vancouver, Washington
  37. Kogarah, New South Wales
  38. Daw Park, South Australia
  39. Heidelberg, Victoria
  40. Wien,
  41. Wien,
  42. Wien,
  43. Wien,
  44. Genk,
  45. Hasselt,
  46. Kortrijk,
  47. Liège,
  48. Goiania, GO
  49. Curitiba, PR
  50. Porto Alegre, RS
  51. Sao Paulo, SP
  52. Winnipeg, Manitoba
  53. Hamilton, Ontario
  54. Hamilton, Ontario
  55. Ottawa, Ontario
  56. Montreal, Quebec
  57. Pointe Claire, Quebec
  58. Amiens,
  59. Lyon,
  60. Orleans Cedex 1,
  61. Orleans,
  62. Paris,
  63. Paris,
  64. Berlin,
  65. Berlin,
  66. Erlangen,
  67. Frankfurt am Main,
  68. Halle,
  69. Hamburg,
  70. Koeln,
  71. Leipzig,
  72. Rheine,
  73. Wuerzburg,
  74. Croom, Co. Limerick
  75. Dublin,
  76. Firenze,
  77. Jesi,
  78. Busan,
  79. Daegu,
  80. Seoul,
  81. San Juan,
  82. Santiago de Compostela, A Coruña
  83. Merida, Badajoz
  84. Bilbao, Bizkaia
  85. Santander, Cantabria
  86. Baracaldo, Vizcaya
  87. Madrid,
  88. Valencia,
  89. Niao Sung Hsiang, Kaohsiung County
  90. Kweishan, Taoyuan County
  91. Changhua,
  92. Kaohsiung,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Arthritis, RheumatoidA 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
NCT00847613
  1. Huntsville, Alabama
  2. Tucson, Arizona
  3. San Diego, California
  4. Santa Maria, California
  5. Colorado Springs, Colorado
  6. Gainesville, Florida
  7. Jacksonville, Florida
  8. Sarasota, Florida
  9. Tampa, Florida
  10. Zephyrhills, Florida
  11. Morton Grove, Illinois
  12. Dubuque, Iowa
  13. Lexington, Kentucky
  14. Baltimore, Maryland
  15. Wheaton, Maryland
  16. Worcester, Massachusetts
  17. Bingham Farms, Michigan
  18. Kalamazoo, Michigan
  19. Edina, Minnesota
  20. Columbia, Missouri
  21. Columbia, Missouri
  22. Lee's Summit, Missouri
  23. Omaha, Nebraska
  24. Omaha, Nebraska
  25. Albany, New York
  26. Binghamton, New York
  27. Syracuse, New York
  28. Dayton, Ohio
  29. Pittsburgh, Pennsylvania
  30. Wyomissing, Pennsylvania
  31. Greenville, South Carolina
  32. Knoxville, Tennessee
  33. Dallas, Texas
  34. Houston, Texas
  35. San Antonio, Texas
  36. Clarksburg, West Virginia
  37. Franklin, Wisconsin
  38. Maroochydore, Queensland
  39. Woodville, South Australia
  40. Malvern East, Victoria
  41. Goiania, GO
  42. Curitiba, PR
  43. Porto Alegre, Rio Grande do Sul
  44. Rio de Janeiro, RJ
  45. Porto Alegre, RS
  46. Porto Alegre, RS
  47. Sao Paulo, SP
  48. Sao Paulo, SP
  49. Plovdiv,
  50. Plovdiv,
  51. Sofia,
  52. Sofia,
  53. Edmonton, Alberta
  54. Victoria, British Columbia
  55. St. John's, Newfoundland and Labrador
  56. Hamilton, Ontario
  57. Newmarket, Ontario
  58. Toronto, Ontario
  59. Montreal, Quebec
  60. Quebec,
  61. Medellin, Antioquia
  62. Barranquilla, Atlantico
  63. Bogota, Cundinamarca
  64. Bucaramanga, Santander
  65. Brno - Zidenice,
  66. Brno,
  67. Hostivice,
  68. Pardubice,
  69. Praha 11 - Chodov,
  70. Praha 1,
  71. Praha 2,
  72. Zlin,
  73. Thessaloniki,
  74. Hyderabad, Andhra Pradesh
  75. Secunderabad, Andhra Pradesh
  76. Hyderabad, Andra Pradesh
  77. Bangalore, Karnataka
  78. Bangalore, Karnataka
  79. Mangalore, Karnataka
  80. Pune, Maharashtra
  81. Kitakyusyu, Fukuoka
  82. Higashihiroshima, Hiroshima
  83. Hitachi-shi, Ibaraki
  84. Sagamihara, Kanagawa
  85. Koushi, Kumamoto
  86. Sendai, Miyagi
  87. Ohmura, Nagasaki
  88. Sasebo, Nagasaki
  89. Ureshino-shi, Saga
  90. Kawagoe-shi, Saitama
  91. Hamamatsu, Shizuoka
  92. Bunkyo-ku, Tokyo
  93. Shinjuku-ku, Tokyo
  94. Shinjuku-ku, Tokyo,
  95. Daejeon,
  96. Incheon,
  97. Seoul,
  98. Seoul,
  99. Seoul,
  100. Seoul,
  101. Seoul,
  102. Seoul,
  103. Mexico, DF
  104. Morelia, Michoacan
  105. Warszawa,
  106. Wroclaw,
  107. Kaohsiung,
  108. Kweishan, Taoyuan County,
  109. Taichung,
  110. Tainan,
  111. Taipei,
  112. Taipei,
  113. Simferopol, Crimea
  114. Kharkiv,
  115. Kyiv,
  116. Lviv,
  117. Vinnitsa,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
 (submitted: August 13, 2019)
185
Original Estimated Enrollment
 (submitted: March 2, 2017)
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:

  • 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.
Sex/Gender
Sexes Eligible for Study:All
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
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2019