NCT02969044

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
9 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

December 20, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 4, 2018

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

12 months

First QC Date

November 17, 2016

Results QC Date

November 6, 2018

Last Update Submit

November 6, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8

    The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (\<=) 3.3 indicates disease remission, greater than (\>) 3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.

    Baseline, Week 8

Secondary Outcomes (17)

  • Number of Participants With Vital Signs Abnormalities

    Baseline up to Week 12

  • Number of Participants With Laboratory Abnormalities

    Baseline up to Week 12

  • Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Baseline up to Week 12

  • Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6

    Baseline, Week 1, 2, 4 and 6

  • Remission Rate Based on Simple Disease Activity Index Score

    Week 4, 6 and 8

  • +12 more secondary outcomes

Study Arms (2)

PF-06651600

EXPERIMENTAL

Study Drug

Drug: PF-06651600

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PlaceboDRUG
Placebo
PF-06651600DRUG

200mg pill every day (QD) for 8 weeks

PF-06651600

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

California Medical Research Associates Inc.

Northridge, California, 91324, United States

Location

Clayton Medical Associates, PC

St Louis, Missouri, 63117, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Southwest Rheumatology Research, LLC

Mesquite, Texas, 75150, United States

Location

MHAT "Trimontsium" Department of Internal Diseases

Plovdiv, 4000, Bulgaria

Location

UMHAT Kaspela, Clinic of Rheumatology

Plovdiv, 4001, Bulgaria

Location

Medical Centre "Pirogov"

Sofia, 1606, Bulgaria

Location

Medical Center Equita

Varna, 9000, Bulgaria

Location

Medical Center "Sveti Ivan Rilski"

Vidin, 3700, Bulgaria

Location

MEDICAL PLUS, s.r.o.

Uherské Hradiště, 686 01, Czechia

Location

LTD "Unimed Ajara" Batumi Referral Hospital

Batumi, 6010, Georgia

Location

LTD Israeli-Georgian Medical Research Clinic ,,Helsicore"

Tbilisi, 0112, Georgia

Location

Ltd Institute of Clinical Cardiology

Tbilisi, 0159, Georgia

Location

LTD Unimedi Kakheti

Tbilisi, 0159, Georgia

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Rheumatologische Schwerpunktpraxis

Berlin, 12161, Germany

Location

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly

Nyíregyháza, H-4400, Hungary

Location

NZOZ Centrum Medyczne Sw. Lukasza w Kartuzach

Kartuzy, 83-300, Poland

Location

Care Clinic Sp. z o.o.

Katowice, 40-060, Poland

Location

Silmedic Sp. z o.o. Oddzial w Katowicach

Katowice, 40-282, Poland

Location

Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.

Oświęcim, 32-600, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Clinic of Dermatovenerology "Prof. Zecevic"

Belgrade, 11000, Serbia

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Polyclinic Medikom

Belgrade, 11000, Serbia

Location

Institute of Treatment and Rehabilitation "Niska Banja"

Niška Banja, 18205, Serbia

Location

AAGS s.r.o., Reumatologicka ambulancia

Dunajská Streda, 92901, Slovakia

Location

MUDr. Zuzana Cizmarikova s.r.o. , Reumatologicka ambulancia

Poprad, 058 01, Slovakia

Location

Nestatna reumatologicka ambulancia

Považská Bystrica, 017 01, Slovakia

Location

Reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.

Žilina, 01001, Slovakia

Location

Related Publications (3)

  • Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.

    PMID: 37917289DERIVED

  • Purohit V, Huh Y, Wojciechowski J, Plotka A, Salts S, Antinew J, Dimitrova A, Nicholas T. Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. AAPS J. 2023 Mar 28;25(3):32. doi: 10.1208/s12248-023-00792-8.

    PMID: 36977960DERIVED

  • 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.

    PMID: 32419304DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

PF-06651600

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 21, 2016

Study Start

December 20, 2016

Primary Completion

December 12, 2017

Study Completion

December 12, 2017

Last Updated

December 4, 2018

Results First Posted

December 4, 2018

Record last verified: 2018-11

Locations

SL(4)PL(5)GE(4)BU(5)DE(2)US(4)SE(4)HU(1)CZ(1)