Clinical trial NCT02969044: Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Official title: A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF biologic).


Eligibility criteria: Inclusion Criteria

* Subjects between the ages of 18 and 75 years, inclusive
* Must have moderate-to-severe, active Rheumatoid Arthritis
* Must have had an inadequate response to Methotrexate
* Subjects may have received one approved TNF inhibiting biologic agent that was inadequately effective and/or not tolerated

Exclusion Criteria

* Subjects with any acute or chronic infections or infection history
* Have acute or active chronic dermatological disorders prior to study start
* Any major illness/condition(s) or evidence of an unstable clinical condition that in the judgment of the investigator would make the subject inappropriate for entry into this study
* Known immunodeficiency disorder or a first degree relative with hereditary immunodeficiency
* Any live (attenuated) vaccines or current routine household contact with anyone who has received live (attenuated) vaccine

Primary outcomes:
measure: Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: Baseline up to Week 12
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to Week 12
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 12
measure: Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6
timeFrame: Baseline, Week 1, 2, 4 and 6
measure: Remission Rate Based on Simple Disease Activity Index Score
timeFrame: Week 4, 6 and 8
measure: Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])
timeFrame: Week 4, 6 and 8
measure: Remission Rate Based on Disease Activity Score (DAS28-4[ESR])
timeFrame: Week 4, 6 and 8
measure: Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])
timeFrame: Week 4, 6 and 8
measure: Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])
timeFrame: Week 4, 6 and 8
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6 and 8
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6 and 8
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6 and 8
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6 and 8
measure: Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6 and 8
measure: Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6 and 8
measure: Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6 and 8
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6 and 8
Other outcomes:
Locations:
city: Northridge
country: United States
facility: California Medical Research Associates Inc.
state: California
city: Saint Louis
country: United States
facility: Clayton Medical Associates, PC
state: Missouri
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Mesquite
country: United States
facility: Southwest Rheumatology Research, LLC
state: Texas
city: Plovdiv
country: Bulgaria
facility: MHAT "Trimontsium" Department of Internal Diseases
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela, Clinic of Rheumatology
city: Sofia
country: Bulgaria
facility: Medical Centre "Pirogov"
city: Varna
country: Bulgaria
facility: Medical Center Equita
city: Vidin
country: Bulgaria
facility: Medical Center "Sveti Ivan Rilski"
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS, s.r.o.
city: Batumi
country: Georgia
facility: LTD "Unimed Ajara" Batumi Referral Hospital
city: Tbilisi
country: Georgia
facility: LTD Israeli-Georgian Medical Research Clinic ,,Helsicore"
city: Tbilisi
country: Georgia
facility: Ltd Institute of Clinical Cardiology
city: Tbilisi
country: Georgia
facility: LTD Unimedi Kakheti
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly
city: Kartuzy
country: Poland
facility: NZOZ Centrum Medyczne Sw. Lukasza w Kartuzach
city: Katowice
country: Poland
facility: Care Clinic Sp. z o.o.
city: Katowice
country: Poland
facility: Silmedic Sp. z o.o. Oddzial w Katowicach
city: Oswiecim
country: Poland
facility: Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Belgrade
country: Serbia
facility: Clinic of Dermatovenerology "Prof. Zecevic"
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: Polyclinic Medikom
city: Niska Banja
country: Serbia
facility: Institute of Treatment and Rehabilitation "Niska Banja"
city: Dunajska Streda
country: Slovakia
facility: AAGS s.r.o., Reumatologicka ambulancia
city: Poprad
country: Slovakia
facility: MUDr. Zuzana Cizmarikova s.r.o. , Reumatologicka ambulancia
city: Povazska Bystrica
country: Slovakia
facility: Nestatna reumatologicka ambulancia
city: Zilina
country: Slovakia
facility: Reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Robinson MF, Damjanov N, Stamenkovic B, Radunovic G, Kivitz A, Cox L, Manukyan Z, Banfield C, Saunders M, Chandra D, Vincent MS, Mancuso J, Peeva E, Beebe JS. Efficacy and Safety of PF-06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor, in Patients With Moderate-to-Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2020 Oct;72(10):1621-1631. doi: 10.1002/art.41316. Epub 2020 Sep 7.