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

  • STATUS
    Recruiting
  • End date
    Feb 4, 2022
  • participants needed
    450
  • sponsor
    Pfizer
Updated on 27 September 2021
Investigator
Pfizer CT.gov Call Center
Primary Contact
Huniko Kereskedelmi s Eg szs g gyi Szolg ltat Kft. (0.3 mi away) Contact
+180 other location
methotrexate
tofacitinib
rheumatism
high sensitivity
erythrocyte sedimentation

Summary

Dual objectives of increased efficacy compared to currently available SoC RA drugs and maintaining a favourable benefit - risk relationship.

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric)
Treatment tofacitinib, PF-06651600, PF-06650833
Clinical Study IdentifierNCT04413617
SponsorPfizer
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

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 38C (100.4F) 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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