A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

INTERVENTION: Product Code: PF‐06651600 Pharmaceutical Form: Tablet INN or Proposed INN: not yet assigned Current Sponsor code: PF‐06651600 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: RHEUMATOID ARTHRITIS ; MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of PF‐06651600; at 8 weeks in subjects with moderate to; severe active RA. Primary end point(s): Change from baseline in simple disease activity index; (SDAI) at Week 8. Secondary Objective: ‐ To evaluate the safety of PF‐06651600.; ‐ To assess other signs of clinical efficacy; over 8 weeks.; ‐ To assess the effect of PF‐06651600 on; patient reported outcome measurements. Timepoint(s) of evaluation of this end point: 8 weeks SECONDARY OUTCOME: Secondary end point(s): ‐Safety and tolerability of PF‐06651600 versus placebo; ; vital signs, laboratory tests, adverse events (AEs) ; including infections, and Serious Adverse Events ; (SAEs). ; ‐Change from baseline in SDAI at Weeks 1, 2, 4 and 6. ; ‐Change from baseline in SDAI low disease activity ; scale (LDAS) and remission rates at Week 4, Week 6 ; and Week 8 ; ‐Change from baseline in DAS28 LDAS and remission ; rates at Week 4, Week 6 and Week 8. ; The following will also be calculated at Weeks 1, 2,4, 6 ; and 8: ; ‐Change from baseline in DAS28‐3 (ESR), DAS28‐3 ; (CRP), DAS28 ‐4 (ESR), and DAS28‐4 (CRP). ; ‐Change from baseline in hsCRP. ; ‐Change from baseline in the Tender/Painful and ; Swollen Joint Count (28). ; ‐Change from baseline in the Physician’s Global ; Assessment of Arthritis. ; Change from baseline in the Patient’s Assessment of ; Arthritis Pain (VAS) and Patient’s Global Assessment ; of Arthritis (VAS) at Weeks 1, 2, 4, 6 and 8. ; ‐Change from baseline in the HAQ‐DI at Weeks 1, 2, 4, ; 6 and 8. Timepoint(s) of evaluation of this end point: 8 weeks INCLUSION CRITERIA: 1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 3. Male and female subjects (including Women of Childbearing Potential (WOCBP)) between the ages of 18 and 75 years, inclusive. For subjects >70 years old, the site must discuss subject eligibility with the study team to ensure that these subjects are sufficiently healthy to participate. 4. Female subjects of childbearing potential must test negative for pregnancy at screening visit and baseline visit. 5. Female subjects of nonchildbearing potential must meet at least 1 of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a