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

Last updated on May 24, 2018

FOR MORE INFORMATION
Study Location
Clinical and Translational Research Center of Alabama, PC
Tuscaloosa, Alabama, 35406 United States
Contact
1-800-718-1021
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.

NCT02996500
Pfizer
Recruiting
Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate

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Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: PF-06650833
    Investigational
  • Drug: Placebo
    Placebo
  • Drug: Tofacitinib
    Investigational
    Other Name: Xeljanz
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
October 2, 2018
October 2, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
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
 
 
NCT02996500
B7921005
2016-002337-30 ( EudraCT Number )
IRAK 4 ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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