Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT02092467 |
Recruitment Status :
Completed
First Posted : March 20, 2014
Results First Posted : August 17, 2021
Last Update Posted : August 17, 2021
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Arthritis, Rheumatoid |
Interventions |
Drug: tofacitinib Biological: adalimumab Biological: etanercept |
Enrollment | 4372 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Study started from 14 March 2014 and completed on 22 July 2020. |
Arm/Group Title | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | TNFi |
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Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug. | Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug. | In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug. |
Period Title: Overall Study | |||
Started | 1457 | 1457 | 1458 |
Treated | 1455 | 1456 | 1451 |
Completed | 1053 | 998 | 1060 |
Not Completed | 404 | 459 | 398 |
Reason Not Completed | |||
Death | 49 | 66 | 38 |
Lost to Follow-up | 38 | 35 | 40 |
Global Deterioration of Health Status | 1 | 0 | 0 |
Other | 32 | 30 | 24 |
Withdrawal by Subject | 282 | 327 | 289 |
Randomized but not treated | 2 | 1 | 7 |
Baseline Characteristics
Arm/Group Title | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | TNFi | Total | |
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Participants received tofacitinib 5 milligram (mg) oral tablet twice daily (BID) up to 72 months. Participants were followed up for at least 28 days after last dose of study drug. | Participants received tofacitinib 10 mg oral tablets (two tablets of 5 mg each) BID up to 72 months. Dose was reduced to tofacitinib 5 mg BID on or after 19 February 2019 as per Study Protocol Amendment 8. Participants were followed up for at least 28 days after last dose of study drug. | In the United States (US), Puerto Rico and Canada, participants randomized to tumor necrosis factor inhibitor (TNFi) arm received adalimumab 40 mg every other week (QOW) by subcutaneous (SC) injection and in all other countries, participants randomized to TNFi arm received etanercept 50 mg once weekly by SC injection up to 72 months. Participants were followed up for at least 28 days after last dose of study drug. | Total of all reporting groups | |
Overall Number of Baseline Participants | 1455 | 1456 | 1451 | 4362 | |
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Safety Analysis Set (SAS) included all participants who were randomized in the study and received at least one dose of the randomized investigational drug (tofacitinib or TNFi).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 1455 participants | 1456 participants | 1451 participants | 4362 participants | |
60.75 (6.80) | 61.40 (7.07) | 61.30 (7.47) | 61.15 (7.12) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1455 participants | 1456 participants | 1451 participants | 4362 participants | |
Female |
1169 80.3%
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1124 77.2%
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1117 77.0%
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3410 78.2%
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Male |
286 19.7%
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332 22.8%
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334 23.0%
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952 21.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1455 participants | 1456 participants | 1451 participants | 4362 participants | |
Hispanic or Latino |
438 30.1%
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482 33.1%
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470 32.4%
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1390 31.9%
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Not Hispanic or Latino |
1017 69.9%
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974 66.9%
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981 67.6%
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2972 68.1%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Race | Number Analyzed | 1455 participants | 1456 participants | 1451 participants | 4362 participants |
White |
1128 77.5%
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1126 77.3%
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1099 75.7%
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3353 76.9%
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Black or African American |
63 4.3%
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65 4.5%
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83 5.7%
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211 4.8%
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Asian |
65 4.5%
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56 3.8%
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55 3.8%
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176 4.0%
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Other |
199 13.7%
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209 14.4%
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214 14.7%
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622 14.3%
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Outcome Measures
Adverse Events