NCT02187055

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,152 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhematoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-07-10
• Last updated: 2018-06-27
• Results posted: 2018-06-27

Locations

215 sites across 25 countries: United States, Argentina, Australia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, Czechia, Estonia, Israel, Latvia, Lithuania, Mexico, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom