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Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
PF-06651600
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Medical Research Associates Inc.
  • Clayton Medical Associates, PC
  • Altoona Center For Clinical Research
  • Southwest Rheumatology Research, LLC
  • MHAT "Trimontsium" Department of Internal Diseases
  • UMHAT Kaspela, Clinic of Rheumatology
  • Medical Centre "Pirogov"
  • Medical Center Equita
  • Medical Center "Sveti Ivan Rilski"
  • MEDICAL PLUS, s.r.o.
  • LTD "Unimed Ajara" Batumi Referral Hospital
  • LTD Israeli-Georgian Medical Research Clinic ,,Helsicore"
  • Ltd Institute of Clinical Cardiology
  • LTD Unimedi Kakheti
  • ISA - Interdisciplinary Study Association GmbH
  • Rheumatologische Schwerpunktpraxis
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly
  • NZOZ Centrum Medyczne Sw. Lukasza w Kartuzach
  • Care Clinic Sp. z o.o.
  • Silmedic Sp. z o.o. Oddzial w Katowicach
  • Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.
  • Centrum Medyczne Oporow
  • Clinic of Dermatovenerology "Prof. Zecevic"
  • Institute of Rheumatology
  • Polyclinic Medikom
  • Institute of Treatment and Rehabilitation "Niska Banja"
  • AAGS s.r.o., Reumatologicka ambulancia
  • MUDr. Zuzana Cizmarikova s.r.o. , Reumatologicka ambulancia
  • Nestatna reumatologicka ambulancia
  • Reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-06651600

Placebo

Arm Description

Study Drug

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Vital Signs Abnormalities
Criteria: sitting pulse rate less than (<) 40 beats per minute (bpm) or >120 bpm; sitting systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or <50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.
Number of Participants With Laboratory Abnormalities
Hemoglobin(Hb);hematocrit;RBC count:<0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:<0.9*LLN or>1.1*upper limit of normal (ULN), platelet:<0.5*LLN or >1.75*ULN,reticulocytes <0.5*LLN or >1.5*ULN,leukocytes <0.6*LLN or >1.5*ULN,lymphocyte;neutrophil: <0.8*LLN or >1.2*ULN,basophil;eosinophil; monocyte:>1.2*ULN,partial thromboplastin time,prothrombin time>1.1*ULN,bilirubin>1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:>3.0*ULN,protein;albumin;LDL, HDL cholesterol:<0.8*LLN or >1.2*ULN;urea nitrogen;creatinine: >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride;calcium; bicarbonate:<0.9*LLN or >1.1*ULN,glucose <0.6*LLN or >1.5*ULN, creatine kinase: >2.0*ULN;urine pH <4.5 or >8,urine glucose or ketones>=1,urine protein;urineHb>=1,urobilinogen;bilirubin;nitrite;leukocyte esterase >=1,urine erythrocytes, leukocytes>=20,hyaline cast>1,bacteria>20.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Remission Rate Based on Simple Disease Activity Index Score
Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])
Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
Remission Rate Based on Disease Activity Score (DAS28-4[ESR])
Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])
Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])
Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.
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
DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
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
DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
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
DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
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
DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8
Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8
Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
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
PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8
HAQ-DI assess degree of difficulty a participant experienced (during past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: average of the sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.

Full Information

First Posted
November 17, 2016
Last Updated
November 6, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02969044
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 20, 2016 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
December 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06651600
Arm Type
Experimental
Arm Description
Study Drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
PF-06651600
Intervention Description
200mg pill every day (QD) for 8 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Number of Participants With Vital Signs Abnormalities
Description
Criteria: sitting pulse rate less than (<) 40 beats per minute (bpm) or >120 bpm; sitting systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or <50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.
Time Frame
Baseline up to Week 12
Title
Number of Participants With Laboratory Abnormalities
Description
Hemoglobin(Hb);hematocrit;RBC count:<0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:<0.9*LLN or>1.1*upper limit of normal (ULN), platelet:<0.5*LLN or >1.75*ULN,reticulocytes <0.5*LLN or >1.5*ULN,leukocytes <0.6*LLN or >1.5*ULN,lymphocyte;neutrophil: <0.8*LLN or >1.2*ULN,basophil;eosinophil; monocyte:>1.2*ULN,partial thromboplastin time,prothrombin time>1.1*ULN,bilirubin>1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:>3.0*ULN,protein;albumin;LDL, HDL cholesterol:<0.8*LLN or >1.2*ULN;urea nitrogen;creatinine: >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride;calcium; bicarbonate:<0.9*LLN or >1.1*ULN,glucose <0.6*LLN or >1.5*ULN, creatine kinase: >2.0*ULN;urine pH <4.5 or >8,urine glucose or ketones>=1,urine protein;urineHb>=1,urobilinogen;bilirubin;nitrite;leukocyte esterase >=1,urine erythrocytes, leukocytes>=20,hyaline cast>1,bacteria>20.
Time Frame
Baseline up to Week 12
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6
Description
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Time Frame
Baseline, Week 1, 2, 4 and 6
Title
Remission Rate Based on Simple Disease Activity Index Score
Description
Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Time Frame
Week 4, 6 and 8
Title
Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])
Description
Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
Time Frame
Week 4, 6 and 8
Title
Remission Rate Based on Disease Activity Score (DAS28-4[ESR])
Description
Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
Time Frame
Week 4, 6 and 8
Title
Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])
Description
Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame
Week 4, 6 and 8
Title
Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])
Description
Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.
Time Frame
Week 4, 6 and 8
Title
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
Description
DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
Time Frame
Baseline, Week 1, 2, 4, 6 and 8
Title
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
Description
DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
Time Frame
Baseline, Week 1, 2, 4, 6 and 8
Title
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
Description
DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame
Baseline, Week 1, 2, 4, 6 and 8
Title
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
Description
DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.
Time Frame
Baseline, Week 1, 2, 4, 6 and 8
Title
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8
Time Frame
Baseline, Week 1, 2, 4, 6 and 8
Title
Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8
Description
Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
Time Frame
Baseline, Week 1, 2, 4, 6 and 8
Title
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
Description
PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
Time Frame
Baseline, Week 1, 2, 4, 6 and 8
Title
Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8
Description
HAQ-DI assess degree of difficulty a participant experienced (during past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: average of the sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
Time Frame
Baseline, Week 1, 2, 4, 6 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
California Medical Research Associates Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Clayton Medical Associates, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Southwest Rheumatology Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
MHAT "Trimontsium" Department of Internal Diseases
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
UMHAT Kaspela, Clinic of Rheumatology
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Medical Centre "Pirogov"
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Medical Center Equita
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Medical Center "Sveti Ivan Rilski"
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Facility Name
MEDICAL PLUS, s.r.o.
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
LTD "Unimed Ajara" Batumi Referral Hospital
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Facility Name
LTD Israeli-Georgian Medical Research Clinic ,,Helsicore"
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Ltd Institute of Clinical Cardiology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
LTD Unimedi Kakheti
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
ISA - Interdisciplinary Study Association GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Rheumatologische Schwerpunktpraxis
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly
City
Nyiregyhaza
ZIP/Postal Code
H-4400
Country
Hungary
Facility Name
NZOZ Centrum Medyczne Sw. Lukasza w Kartuzach
City
Kartuzy
ZIP/Postal Code
83-300
Country
Poland
Facility Name
Care Clinic Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-060
Country
Poland
Facility Name
Silmedic Sp. z o.o. Oddzial w Katowicach
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Clinic of Dermatovenerology "Prof. Zecevic"
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Polyclinic Medikom
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Treatment and Rehabilitation "Niska Banja"
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
AAGS s.r.o., Reumatologicka ambulancia
City
Dunajska Streda
ZIP/Postal Code
92901
Country
Slovakia
Facility Name
MUDr. Zuzana Cizmarikova s.r.o. , Reumatologicka ambulancia
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Nestatna reumatologicka ambulancia
City
Povazska Bystrica
ZIP/Postal Code
017 01
Country
Slovakia
Facility Name
Reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.
City
Zilina
ZIP/Postal Code
01001
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
32419304
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981006&StudyName=A+Phase+2a%2C+Randomized%2C+Double-blind%2C+Parallel+Group%2C+Placebo-controlled%2C+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
Description
To obtain contact information for a study center near you, click here.
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981006&StudyName=A+Phase+2a%2C+Randomized%2C+Double-blind%2C+Parallel+Group%2C+Placebo+Controlled%2C+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
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

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