Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:11/2/2018
Start Date:November 2016
End Date:August 2018

Use our guide to learn which trials are right for you!

A 12 Week Randomized, Double-blind, Double Dummy, Parallel Group, Active And Placebo-controlled, Multicenter Study To Assess The Efficacy And Safety Profile Of Pf-06650833 In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate

This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and
active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at
Week 12 in subjects with moderate-severe, active, RA who have had an inadequate response to
MTX. PF-06650833 or matching placebo tablets will be administered orally QD under fasting
conditions, and tofacitinib or matching tofacitinib placebo tablets will be administered
orally BID for 12 weeks in a blinded fashion.


Inclusion Criteria:

1. Male and female (including WOCBP) subjects between the ages of 18 and 75 years,
inclusive.

2. Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European
League Against Rheumatism (EULAR) classification criteria for RA with a Total Score
≥6/10.

3. The subject has active disease at both Screening and Baseline, as defined by both:

- 6 joints tender or painful on motion, AND

- 6 joints swollen; and fulfills 1 of the following 2 criteria at Screening:

- High sensitivity C reactive protein (hsCRP) >7 mg/L at screening

- Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm/hr;

4. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status
in RA.

5. Subjects must be ACPA positive between screening and randomization.

6. Subjects must have been taking oral MTX for at least 3 months at an adequate dose to
determine that the subject had an inadequate response to MTX

7. Up to 50 % of subjects may have received one (and only one) approved TNF-inhibiting
biologic agent administered that was inadequately effective and/or not tolerated. The
anti-TNF biologic could also have been discontinued due to lack of continued access.

Exclusion Criteria:

1. Subjects with a known immunodeficiency disorder or a first degree relative with a
hereditary immunodeficiency.

2. Subjects with any of the following infections or infections history:

1. Any infection requiring treatment within 2 weeks prior to screening (Visit 1).

2. Any infection requiring hospitalization, parenteral antimicrobial therapy within
60 days, or as otherwise judged to be an opportunistic infection or clinically
significant by the investigator, within the past 6 months.

3. Infected joint prosthesis at any time with the prosthesis still in situ.

4. Recurrent (more than one episode) herpes zoster or disseminated (a single
episode) herpes zoster or disseminated (a single episode) herpes simplex.

5. Subjects will be screened for HIV. Subjects who test positive for HIV will be
excluded from the study.

6. Subjects will be screened for hepatitis B virus infection and will be excluded if
positive for hepatitis B surface antigen (HBsAg). Subjects with HBsAg negative
testing but who test positive for hepatitis B core antibody (HBcAb) must have
further testing for hepatitis B surface antibody (HBsAb). If HBsAb is negative,
the subject will be excluded from the study.

7. Subjects with clinically significant active hepatic disease or hepatic impairment
by laboratory assessment.

8. Subjects will be screened for hepatitis C virus (HCV Ab). Subjects with positive
HCV Ab tests will be reflex tested for HCV ribonucleic acid (HCV RNA). Only
subjects with negative HCV Ab or HCV RNA will be allowed to enroll in the study.

3. Evidence of active or latent, untreated or inadequately treated infection with
Mycobacterium tuberculosis (TB)

4. Pre-existing chronic autoimmune disease.
We found this trial at
14
sites
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Baytown, Texas 77521
?
mi
from
Baytown, TX
Click here to add this to my saved trials
Bowling Green, Kentucky 42101
?
mi
from
Bowling Green, KY
Click here to add this to my saved trials
Canton, Georgia 30114
?
mi
from
Canton, GA
Click here to add this to my saved trials
Clearwater, Florida 33765
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Houston, Texas 77004
?
mi
from
Houston, TX
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Monroe, Louisiana 71203
?
mi
from
Monroe, LA
Click here to add this to my saved trials
South Miami, Florida 33143
?
mi
from
South Miami, FL
Click here to add this to my saved trials
South Miami, Florida 33143
?
mi
from
South Miami, FL
Click here to add this to my saved trials
Tomball, Texas 77375
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Tucson, Arizona 85723
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tuscaloosa, AL
Click here to add this to my saved trials