An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate (ORAL STRATEGY)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Rhematoid Arthritis

Treatments: Drug: Tofacitinib with methotrexate; Biological: Adalimumab with methotrexate; Drug: Tofacitinib without methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02187055

ORAL STRATEGY (Other Identifier)

2014-000358-13 (EudraCT Number)

A3921187

Details and patient eligibility

About

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.

Enrollment: 1,152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,152 participants in 3 patient groups

Tofacitinib 5 mg twice daily with methotrexate

Experimental group

Treatment:

Drug: Tofacitinib with methotrexate

Tofacitinib 5 mg twice daily monotherapy

Experimental group

Treatment:

Drug: Tofacitinib without methotrexate

Adalimumab with methotrexate

Active Comparator group

Treatment:

Biological: Adalimumab with methotrexate