ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 April 2022
Main ID:	NCT03334851
Date of registration:	03/11/2017
Prospective Registration:	Yes
Primary sponsor:	Pfizer
Public title:	Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
Scientific title:	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
Date of first enrolment:	November 17, 2017
Target sample size:	74
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03334851
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 1

Countries of recruitment
Puerto Rico	United States

Contacts

Name:	Pfizer CT.gov Call Center
Address:
Telephone:
Email:
Affiliation:	Pfizer

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Systemic Lupus Erythematosus

Intervention(s)

Drug: PF-06835375

Drug: Placebo

Primary Outcome(s)

Number of participants with adverse events (AEs) by seriousness and relationship to treatment [Time Frame: Day 1 through approximately Day 112]

Number of participants with clinically relevant changes from baseline in vital signs [Time Frame: Day 1 through approximately Day 112]

Number of participants with change from baseline in labboratory test results [Time Frame: Day 1 through approximately Day 112]

Number of participants with infections [Time Frame: Day 1 through approximately Day 112]

Number of participants with clinically relevant changes from baseline in ECG parameters [Time Frame: Day 1 through approximately Day 112]

Number of participants with dose limiting adverse events [Time Frame: Day 1 through approximately Day 112]

Secondary Outcome(s)

Maximum Observed Plasma Concentration (Cmax) of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Change from baseline in the number of specific T cells (subset) over time following single and multiple doses of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Bioavailability of PF-06835375 subcutaneous doses compared to intravenous doses of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Number of participants with anti-drug antibodies (ADA) to PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Apparent Clearance (CL) of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Average Concentration (Cav) of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Change from baseline in the number of specific B cells (subset) over time following single and multiple doses of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Mean residence of time for PF-06835375 [Time Frame: Day 1 though approximately Day 112]

Plasma Decay Half-Life of PF-06835375 [Time Frame: Day 1 to approximately Day 112]

AUCtau of PF-06835375 (dose normalized) [Time Frame: Day 1 through approximately Day 112]

Number of participants with neutralizing antibodies to PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Volume of Distribution at Steady State (Vss) of PF-06835375 [Time Frame: Day 1 through approximately Day 112]

Secondary ID(s)

2017-003077-34

C1131001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.