An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

NCT02187055

Last updated date
Study Location
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801, United States
Contact
1-800-718-1021

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

- Have moderate to severe rheumatoid arthritis

- On methotrexate but inadequately controlled

- Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection

- Subjects must use contraception

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects who have been previously treated with adalimumab or Tofacitinib


- Subjects 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.


- Subjects with specific laboratory test abnormalities


- Subjects with specific types of infections

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[email protected]

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Rhematoid ArthritisAn Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
NCT02187055
  1. Huntsville, Alabama
  2. Gilbert, Arizona
  3. Covina, California
  4. Fullerton, California
  5. Huntington Beach, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Placentia, California
  11. San Diego, California
  12. Upland, California
  13. Van Nuys, California
  14. Whittier, California
  15. Bridgeport, Connecticut
  16. Aventura, Florida
  17. Aventura, Florida
  18. Edgewater, Florida
  19. Fort Lauderdale, Florida
  20. Jacksonville, Florida
  21. Orlando, Florida
  22. Palm Harbor, Florida
  23. Pensacola, Florida
  24. Tamarac, Florida
  25. Tampa, Florida
  26. Vero Beach, Florida
  27. Vero Beach, Florida
  28. Winter Garden, Florida
  29. Coeur d'Alene, Idaho
  30. Idaho Falls, Idaho
  31. Vernon Hills, Illinois
  32. Indianapolis, Indiana
  33. Baton Rouge, Louisiana
  34. Monroe, Louisiana
  35. Frederick, Maryland
  36. Kalamazoo, Michigan
  37. Flowood, Mississippi
  38. Saint Louis, Missouri
  39. Springfield, Missouri
  40. Plainview, New York
  41. Salisbury, North Carolina
  42. Salisbury, North Carolina
  43. Wilmington, North Carolina
  44. Minot, North Dakota
  45. Oklahoma City, Oklahoma
  46. Duncansville, Pennsylvania
  47. Philadelphia, Pennsylvania
  48. Charleston, South Carolina
  49. Jackson, Tennessee
  50. Baytown, Texas
  51. Dallas, Texas
  52. Dallas, Texas
  53. Houston, Texas
  54. Houston, Texas
  55. Houston, Texas
  56. Lubbock, Texas
  57. Mesquite, Texas
  58. San Antonio, Texas
  59. San Antonio, Texas
  60. Spokane, Washington
  61. Caba, Buenos Aires
  62. San Miguel de Tucuman, Tucuman
  63. San Miguel de Tucuman, Tucuman
  64. Buenos Aires,
  65. San Juan,
  66. Camperdown, New South Wales
  67. Southport, Queensland
  68. Southport, Queensland
  69. Woodville South, South Australia
  70. Malvern East, Victoria
  71. Victoria Park, Western Australia
  72. Banja Luka, Republika Srpska
  73. Tuzla,
  74. Pleven,
  75. Plovdiv,
  76. Plovdiv,
  77. Ruse,
  78. Ruse,
  79. Shumen,
  80. Sofia,
  81. Sofia,
  82. Targovisthe,
  83. Kitchener, Ontario
  84. Trois-Rivieres, Quebec
  85. Santiago, Metropolitana
  86. Vina del Mar, Valparaiso
  87. Puerto Varas, X Region
  88. Puerto Varas, X Region
  89. Brno - Zidenice, Czech Republic
  90. Brno,
  91. Ceska Lipa,
  92. Ostrava- Moravska Ostrava,
  93. Praha 4,
  94. Parnu,
  95. Tallinn,
  96. Tallinn,
  97. Haifa,
  98. Haifa,
  99. Jerusalem,
  100. Tel-Hashomer,
  101. Jung-Gu, Incheon
  102. Daegu,
  103. Daegu,
  104. Gwangju,
  105. Seoul,
  106. Seoul,
  107. Riga,
  108. Riga,
  109. Alytus,
  110. Kaunas,
  111. Siauliai,
  112. Torreon, Coahuila
  113. Mexico, Distrito Federal
  114. Guadalajara, Jalisco
  115. Culiacan, Sinaloa
  116. Culiacan, Sinaloa
  117. Merida, Yucatan
  118. Merida, Yucatan
  119. Merida, Yucatan
  120. Merida, Yucatan
  121. Chihuahua,
  122. Jalisco,
  123. San Luis Potosi,
  124. San Luis Potosi,
  125. Arequipa,
  126. Lima,
  127. Lima,
  128. Lima,
  129. Lipa City, Batangas
  130. Davao, Davao DEL SUR
  131. Iloilo City, Iloilo
  132. Manila, Metro Manila
  133. Manila, Metro Manila
  134. Quezon City, Metro Manila
  135. Quezon City, Metro Manila
  136. Cebu City,
  137. Davao,
  138. Iloilo City,
  139. Krakow, Malopolska
  140. Warszawa, WOJ Mazowieckie
  141. Bydgoszcz,
  142. Bytom,
  143. Bytom,
  144. Elblag,
  145. Gdynia,
  146. Katowice,
  147. Lodz,
  148. Nadarzyn,
  149. Poznan,
  150. Warszawa,
  151. Warszawa,
  152. Wroclaw,
  153. Cluj Napoca, Cluj
  154. Sfantu Gheorghe, Covasna
  155. Baia Mare, Maramures
  156. Baia Mare, Maramures
  157. Bucuresti,
  158. Bucuresti,
  159. Bucuresti,
  160. Bucuresti,
  161. Bucuresti,
  162. Galati,
  163. Iasi,
  164. Petrozawodsk, Karelia Republic
  165. Petrozawodsk, Karelia Republic
  166. Kemerovo,
  167. Moscow,
  168. Moscow,
  169. Novosibirsk,
  170. Orenburg,
  171. Ryazan,
  172. Saint Petersburg,
  173. Samara,
  174. Saratov,
  175. Smolensk,
  176. Yaroslavl,
  177. Yaroslavl,
  178. Bloemfontein, FREE State
  179. Johannesburg, Gauteng
  180. Johannesburg, Gauteng
  181. Johannesburg, Gauteng
  182. Parktown, Johannesburg, Gauteng
  183. Pretoria, Gauteng
  184. Pretoria, Gauteng
  185. Pretoria, Gauteng
  186. Durban, Kwazulu-natal
  187. Cape Town, Western CAPE
  188. Cape Town, Western CAPE
  189. Stellenbosch, Western CAPE
  190. Santiago de Compostela, A Coruna
  191. A Coruna,
  192. Barcelona,
  193. Madrid,
  194. Malaga,
  195. Sevilla,
  196. Taichung, Taiwan ROC
  197. Hualien,
  198. Kaohsiung,
  199. Kaohsiung,
  200. Taipei,
  201. Taoyuan County,
  202. Bangkok, Rajthevi
  203. Bangkok,
  204. Bangkok,
  205. Bangkok,
  206. Songkhla,
  207. Ankara,
  208. Samsun,
  209. Samsun,
  210. Sivas,
  211. Dudley, WEST Midlands
  212. Cannock,
  213. Leeds,
  214. Liverpool,
  215. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
Official Title  ICMJE A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis
Brief Summary To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rhematoid Arthritis
Intervention  ICMJE
  • Drug: Tofacitinib with methotrexate
    Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
  • Drug: Tofacitinib without methotrexate
    Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
  • Biological: Adalimumab with methotrexate
    Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months
Study Arms  ICMJE
  • Experimental: Tofacitinib 5 mg twice daily with methotrexate
    Intervention: Drug: Tofacitinib with methotrexate
  • Experimental: Tofacitinib 5 mg twice daily monotherapy
    Intervention: Drug: Tofacitinib without methotrexate
  • Active Comparator: Adalimumab with methotrexate
    Intervention: Biological: Adalimumab with methotrexate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2018)
1152
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2014)
1080
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have moderate to severe rheumatoid arthritis
  • On methotrexate but inadequately controlled
  • Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection
  • Subjects must use contraception

Exclusion Criteria:

  • Subjects who have been previously treated with adalimumab or Tofacitinib
  • Subjects 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.
  • Subjects with specific laboratory test abnormalities
  • Subjects with specific types of infections
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Chile,   Czechia,   Estonia,   Israel,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries Croatia,   Czech Republic,   France
 
Administrative Information
NCT Number  ICMJE NCT02187055
Other Study ID Numbers  ICMJE A3921187
2014-000358-13 ( EudraCT Number )
ORAL STRATEGY ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP