TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

NCT04413617

Last updated date
Study Location
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M3, Canada
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
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female participants between the ages of 18 and 70 years.

- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

- 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.

- The participant has active disease at both Screening and Randomization, as defined by both: ≥6 joints tender or painful on motion, AND ≥6 joints swollen; and fulfills 1 of the following 2 criteria: High sensitivity C reactive protein (hsCRP) >7 mg/L at Screening (Visit 1) as performed by the central laboratory OR Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm h.

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


- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or IP administration or may
interfere with the interpretation of study results and, in the judgment of the
investigator, would make the participant inappropriate for entry into this study.


- Participants with a known immunodeficiency disorder or a first degree relative with a
hereditary immunodeficiency.


- Participants with any active or latent infections.


- Participants with positive hepatitis B surface antigen (HBsAg).


- Participants with positive HCV Ab tests will be reflex tested for HCV ribonucleic acid
(HCV RNA).


- Any history of either untreated or inadequately treated latent or active tuberculosis
(TB) infection, current treatment for active or latent TB infection or evidence of
currently active TB,


- History of a major organ transplant (eg, heart, lung, kidney and liver) or
hematopoietic stem cell/marrow transplant.


- History of severe allergic or anaphylactoid reaction to kinase inhibitors, or
corticosteroid preparations.


- Known history of diverticulitis or symptomatic diverticulosis, perineal abscess or
fistulae.


- Participants with malignancy or history of malignancy (including lymphoma, leukemia,
or lymphoproliferative disease).


- Pre-existing chronic autoimmune disease (eg, inflammatory bowel disease, systemic
lupus erythematosus, moderate-severe atopic dermatitis, dermatomyositis) other than
RA. Secondary Sjogren's Syndrome (due to RA) may be included.


- Participants with fibromyalgia will be excluded.


- Previous treatment with total lymphoid irradiation.


- Participants with an oral, tympanic, or temporal temperature of 38°C (100.4°F) or
higher at baseline.


- Participants may not receive any live/attenuated vaccine from 30 days prior to
randomization during the course of the study, or for 30 days after the last dose of
study medication. Participants who have current routine household contact with
children who have received varicella or oral polio vaccine within 2 months of first
study dose are also excluded.


- History of any lymphoproliferative disorder.


- Have hearing loss with progression over the previous 5 years, sudden hearing loss, or
middle or inner ear disease.


- History of any prior deep vein thrombosis (DVT) or pulmonary embolism [PE].


- Recent (within 6 months of screening) myocardial infarction, coronary
revascularization, or percutaneous angioplasty with or without placement of a coronary
artery stent; acute coronary syndrome; chronic uncompensated heart failure or New York
Heart Association Functional Class III or IV; left ventricular assist devices;
implanted defibrillators.


- Current severe chronic renal insufficiency or renal failure as defined by persistent
(on repeated measurements) eGFR <60 mL/min per 1.73 m2 based on the Chronic Kidney
Disease Epidemiology Collaboration (CKD-EPI) calculation.


- Any known coagulopathy or hypercoagulant syndrome.


- Presence of any of the following laboratory abnormalities at screening or within the 3
months prior to first study dose:


Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥1.5 x the upper
limit of normal (ULN); Participants with a history of Gilbert's syndrome may have a direct
bilirubin measured and would be eligible for this study provided the direct bilirubin is ≤
ULN and other liver function assessments are normal; Absolute neutrophil count of <1.5 x
109/L (<1500/mm3). Participants with cyclic (benign ethnic) neutropenia will be excluded;
Absolute lymphocyte count of <0.5 x 109/L (<500/mm3); Absolute white blood cell (WBC) count
of <3.0 x 109/L (<3000/mm3); Hemoglobin <9.0 g/dL (90 g/L); Platelet count ≤100 x 109/L
(100,000 cells/mm3) or ≥1000 x 109/L (1,000,000 cells/mm3); Thrombocytopenia, as defined by
a platelet count <100 x 109/L (<100,000/mm3) at screening visit or within the 3 months
prior to first study dose. [Screening laboratory tests with abnormal results may be
repeated once to confirm abnormal results. If results return to normal protocol acceptable
limits within the 4-week screening period, the participant may enter the study].


- Grade 3 or greater laboratory abnormality based on the Common Terminology Criteria for
Adverse Events (CTCAE) version 5.0 toxicity scale, except for the following that are
allowed: Grade 3 prothrombin time (PT) secondary to warfarin treatment; Grade 3 partial
thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or
anti-coagulant therapy.


- Participants previously treated with a biologic DMARD (except for up to 25% of
participants who may have been treated with 1, and only 1 prior TNF inhibitor) or any
other recent DMARD treatment (eg, a JAK inhibitor), or participants currently treated
with any other prohibited medications will be excluded.


- Prior use of tofacitinib or other JAK inhibitor in the context of a clinical trial is
excluded. Concomitant use of tofacitinib (other than as prescribed by the
randomization scheme) or other JAK inhibitor is prohibited.


- Participants who have previously been treated with other, non-TNFa inhibiting biologic
DMARDs [including, abatacept (Orencia®), tocilizumab (Actemra®), Sarilumab (Kevzara®),
anakinra (Kineret®), rituximab (Rituxan®) or other selective B lymphocyte depleting
agents, or other lymphocyte depleting agents/therapies (such as alemtuzab [CamPath®],
natalizumab (Tysabri®), alkylating agents [eg, cyclophosphamide or chlorambucil],
total lymphoid irradiation) are excluded from participation in the study.


- Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half-lives preceding the first dose of IP used in this
study (whichever is longer).


- Any 12-lead electrocardiogram (ECG) performed prior to randomization that demonstrates
clinically relevant abnormalities that may affect participant safety or interpretation
of study results.

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Advanced Information
Descriptive Information
Brief Title  ICMJE TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
Official Title  ICMJE A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
Brief Summary Dual objectives of increased efficacy compared to currently available SoC RA drugs and maintaining a favourable benefit - risk relationship.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: PF-06650833
    400 mg
  • Drug: PF-06651600
    100 mg
  • Drug: Tofacitinib
    11 mg
Study Arms  ICMJE
  • Experimental: PF-06650833 + tofacitinib
    Interventions:
    • Drug: PF-06650833
    • Drug: Tofacitinib
  • Experimental: PF-06650833 + PF-06651600
    Interventions:
    • Drug: PF-06650833
    • Drug: PF-06651600
  • Experimental: PF-06650833
    Intervention: Drug: PF-06650833
  • Experimental: PF-06651600
    Intervention: Drug: PF-06651600
  • Experimental: Tofacitinib
    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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2020)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 27, 2022
Estimated Primary Completion Date September 27, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants between the ages of 18 and 70 years.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • 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.
  • The participant has active disease at both Screening and Randomization, as defined by both: ?6 joints tender or painful on motion, AND ?6 joints swollen; and fulfills 1 of the following 2 criteria: High sensitivity C reactive protein (hsCRP) >7 mg/L at Screening (Visit 1) as performed by the central laboratory OR Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm h.

Exclusion Criteria:

  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Participants with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
  • Participants with any active or latent infections.
  • Participants with positive hepatitis B surface antigen (HBsAg).
  • Participants with positive HCV Ab tests will be reflex tested for HCV ribonucleic acid (HCV RNA).
  • Any history of either untreated or inadequately treated latent or active tuberculosis (TB) infection, current treatment for active or latent TB infection or evidence of currently active TB,
  • History of a major organ transplant (eg, heart, lung, kidney and liver) or hematopoietic stem cell/marrow transplant.
  • History of severe allergic or anaphylactoid reaction to kinase inhibitors, or corticosteroid preparations.
  • Known history of diverticulitis or symptomatic diverticulosis, perineal abscess or fistulae.
  • Participants with malignancy or history of malignancy (including lymphoma, leukemia, or lymphoproliferative disease).
  • Pre-existing chronic autoimmune disease (eg, inflammatory bowel disease, systemic lupus erythematosus, moderate-severe atopic dermatitis, dermatomyositis) other than RA. Secondary Sjogren's Syndrome (due to RA) may be included.
  • Participants with fibromyalgia will be excluded.
  • Previous treatment with total lymphoid irradiation.
  • Participants with an oral, tympanic, or temporal temperature of 38°C (100.4°F) or higher at baseline.
  • Participants may not receive any live/attenuated vaccine from 30 days prior to randomization during the course of the study, or for 30 days after the last dose of study medication. Participants who have current routine household contact with children who have received varicella or oral polio vaccine within 2 months of first study dose are also excluded.
  • History of any lymphoproliferative disorder.
  • Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease.
  • History of any prior deep vein thrombosis (DVT) or pulmonary embolism [PE].
  • Recent (within 6 months of screening) myocardial infarction, coronary revascularization, or percutaneous angioplasty with or without placement of a coronary artery stent; acute coronary syndrome; chronic uncompensated heart failure or New York Heart Association Functional Class III or IV; left ventricular assist devices; implanted defibrillators.
  • Current severe chronic renal insufficiency or renal failure as defined by persistent (on repeated measurements) eGFR <60 mL/min per 1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) calculation.
  • Any known coagulopathy or hypercoagulant syndrome.
  • Presence of any of the following laboratory abnormalities at screening or within the 3 months prior to first study dose:

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ?1.5 x the upper limit of normal (ULN); Participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ? ULN and other liver function assessments are normal; Absolute neutrophil count of <1.5 x 109/L (<1500/mm3). Participants with cyclic (benign ethnic) neutropenia will be excluded; Absolute lymphocyte count of <0.5 x 109/L (<500/mm3); Absolute white blood cell (WBC) count of <3.0 x 109/L (<3000/mm3); Hemoglobin <9.0 g/dL (90 g/L); Platelet count ?100 x 109/L (100,000 cells/mm3) or ?1000 x 109/L (1,000,000 cells/mm3); Thrombocytopenia, as defined by a platelet count <100 x 109/L (<100,000/mm3) at screening visit or within the 3 months prior to first study dose. [Screening laboratory tests with abnormal results may be repeated once to confirm abnormal results. If results return to normal protocol acceptable limits within the 4-week screening period, the participant may enter the study].

- Grade 3 or greater laboratory abnormality based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity scale, except for the following that are allowed: Grade 3 prothrombin time (PT) secondary to warfarin treatment; Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy.

  • Participants previously treated with a biologic DMARD (except for up to 25% of participants who may have been treated with 1, and only 1 prior TNF inhibitor) or any other recent DMARD treatment (eg, a JAK inhibitor), or participants currently treated with any other prohibited medications will be excluded.
  • Prior use of tofacitinib or other JAK inhibitor in the context of a clinical trial is excluded. Concomitant use of tofacitinib (other than as prescribed by the randomization scheme) or other JAK inhibitor is prohibited.
  • Participants who have previously been treated with other, non-TNFa inhibiting biologic DMARDs [including, abatacept (Orencia®), tocilizumab (Actemra®), Sarilumab (Kevzara®), anakinra (Kineret®), rituximab (Rituxan®) or other selective B lymphocyte depleting agents, or other lymphocyte depleting agents/therapies (such as alemtuzab [CamPath®], natalizumab (Tysabri®), alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation) are excluded from participation in the study.
  • Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of IP used in this study (whichever is longer).
  • Any 12-lead electrocardiogram (ECG) performed prior to randomization that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04413617
Other Study ID Numbers  ICMJE B7921023
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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 June 2020

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