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Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis

Last updated on September 26, 2018

FOR MORE INFORMATION
Study Location
Pinnacle Research Group, LLC
Anniston, Alabama, 36201 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Lupus Erythematosus, 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

- Patients with Rheumatoid Arthritis: confirmed diagnosis according to 2010 ACR/EULAR
criteria with symptom duration at least 6 months and positive with Rheumatoid Factor
and/or anti citrullinated peptide antibody

- Patients with Systemic Lupus Erythematosus: Confirmed diagnosis according to the SLICC
Classification Criteria with symptom duration at least 6 months and at least one of
the following: positive antinuclear antibody titer, positive anti-dsDNA, anti-Smith
antibodies

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

- Active central nervous system manifestations, systemic vasculitis or
pleuro/pericarditis

- Active lupus nephritis

- Treatment with B cell depleting agents within 52 weeks prior to screening

NCT03334851
Pfizer
Recruiting
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis

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Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
A Phase 1, Randomized, Multi-center, Double-blind, Sponsor Open, Placebo-controlled, Single And Multiple Dose-escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This study will include two parts: Part A and Part B. Part A will consist of single ascending dose cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of approximately 112 subjects at approximately 10 sites.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Systemic Lupus Erythematosus
  • Rheumatoid Arthritis
  • Drug: PF-06835375
    Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
  • Drug: Placebo
    Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
  • Experimental: Part A, Cohort 1
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 2
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 3
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 4
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 5
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 6
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 7
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part A, Cohort 8
    Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part B, Cohort 1
    Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part B, Cohort 2
    Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part B, Cohort 3
    Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part B, Cohort 4
    Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part B, Cohort 5
    Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
  • Experimental: Part B, cohort 6
    Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
    Interventions:
    • Drug: PF-06835375
    • Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
November 15, 2021
November 15, 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Rheumatoid Arthritis: confirmed diagnosis according to 2010 ACR/EULAR criteria with symptom duration at least 6 months and positive with Rheumatoid Factor and/or anti citrullinated peptide antibody
  • Patients with Systemic Lupus Erythematosus: Confirmed diagnosis according to the SLICC Classification Criteria with symptom duration at least 6 months and at least one of the following: positive antinuclear antibody titer, positive anti-dsDNA, anti-Smith antibodies

Exclusion Criteria:

  • Active central nervous system manifestations, systemic vasculitis or pleuro/pericarditis
  • Active lupus nephritis
  • Treatment with B cell depleting agents within 52 weeks prior to screening
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03334851
C1131001
2017-003077-34 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 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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1-800-718-1021

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