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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Adalimumab; Methotrexate; Tofacitinib

Criteria

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