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

NCT02996500

Last updated date
Study Location
Clinical and Translational Research Center of Alabama, PC
Tuscaloosa, Alabama, 35406, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: PF-06650833
    Investigational
  • Drug: Placebo
    Placebo
  • Drug: Tofacitinib
    Investigational
    Other Name: Xeljanz
Study Arms  ICMJE
  • Experimental: Arm 1: 20 mg QD
    PF-06650833 , 20 mg QD
    Intervention: Drug: PF-06650833
  • Experimental: Arm 2: 60 mg QD
    PF-06650833, 60 mg QD
    Intervention: Drug: PF-06650833
  • Experimental: Arm 3: 200 mg QD
    Pf-06650833, 200 mg QD
    Intervention: Drug: PF-06650833
  • Experimental: Arm 4: 400 mg QD
    PF-06650833, 400 mg QD
    Intervention: Drug: PF-06650833
  • Placebo Comparator: Placebo
    Placebo, 0 mg BID
    Intervention: Drug: Placebo
  • Active Comparator: Arm 5: Tofacitinib
    Tofacitinib 5 mg BID
    Intervention: Drug: Tofacitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2018)
269
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2016)
230
Actual Study Completion Date  ICMJE August 15, 2018
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bosnia and Herzegovina,   Bulgaria,   Croatia,   Czechia,   Georgia,   Germany,   Hungary,   Korea, Republic of,   Mexico,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02996500
Other Study ID Numbers  ICMJE B7921005
2016-002337-30 ( EudraCT Number )
IRAK 4 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP