search
Back to results

Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tasocitinib plus Methotrexate
Tofacitinib plus placebo methotrexate
Placebo tofacitinib plus Methotrexate
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Early Rheumatoid Arthritis, Joint Structure, Magnetic Resonance Imaging, Janus Kinase (JAK) Inhibitor, Tasocitinib, Tofacitinib

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients with moderate to severe early rheumatoid arthritis (< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive.

Exclusion Criteria:

  • Pregnant or lactating patients;
  • Patients with renal or hepatic impairment or other severe or progressing disease;
  • Patients with contraindication to magnetic resonance imaging with gadolinium contrast.

Sites / Locations

  • ArthroCare, Arthritis Care & Research, PC
  • Talbert Medical Group
  • Inland Rheumatology Clinical Trials, Inc.
  • Millennium Research
  • DMI Research, Inc.
  • St. Petersburg Arthritis Center
  • Oklahoma Medical Research Foundation
  • Office of John P. Lavery, MD, PA
  • OMI - Organización Médica de Investigación
  • Saint Dennis Medical Group S.A.
  • Consultorios Reumatologicos Pampa
  • Hospital Base Valdivia
  • Consulta Privada Dr. Juan Ignacio Vargas
  • University Hospital Centre Split,Department for Internal Medicine, Division of Clinical Rheumatology
  • General Hospital Sveti Duh
  • ARTMEDI UPD s r.o.
  • DC Mediscan
  • Nemocnice na Frantisku s poliklinikou
  • Nemocnice na Frantisku
  • Revmatologicky ustav
  • Uherskohradistska nemocnice, a.s.
  • Nemocnice Atlas, a.s.
  • PV-Medical s.r.o.
  • Drug Research Center Kft.
  • Orszagos Reumatologiai es Fizioterapias Intezet
  • Synexus Magyarorszag Kft.
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Reumatologiai Tanszek
  • Petz Aladar Megyei Oktato Korhaz/Reumatologiai es Mozgasszervi Rehabilitacios Centrum
  • Centro de Investigacion y Tratamiento Reumatologico S.C.
  • Hospital Angeles Mocel
  • Centro de Investigacion y Tratamiento Reumatologico SC
  • Hospital Angeles Mocel
  • Investigacion y Biomedicina de Chihuahua S.C
  • Hospital Angeles Mocel
  • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorob Kostno-Stawowych J.
  • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
  • Nzoz "Nasz Lekarz"
  • Mindful Medical Research
  • San Juan Arthritis & Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Tofacitinib (CP 690,550) 10 mg BID plus MTX

Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX

Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema
Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.

Secondary Outcome Measures

Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP
Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0â€"3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1â€"33% of bone edematous; 2: 34â€"66% of bone edematous; 3: 67â€"100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.
Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions
Bone erosion assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Each site was scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. OMERACT RAMRIS total erosion score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist is 250 (range 0-250). Increasing score=greater severity.
Modified Total Sharp Score (mTSS) at Months 6 and 12
Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Change From Baseline to Months 6 and 12 in mTSS
Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) + erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Joint Space Narrowing (JSN) Scores at Months 6 and 12
JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Change From Baseline to Months 6 and 12 in JSN Scores
JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Erosion Scores at Months 6 and 12
Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Change From Baseline to Months 6 and 12 in Erosion Score
Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response
ACR20 response: greater than or equal to (≥)20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Participant's Assessment of Pain; Participant's Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Percentage of Participants With an ACR 50% Improvement (ACR50) Response
ACR50 response: ≥ 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of disease activity, 3) Paricipant's Assessment of Pain, 4) Participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.
Percentage of Participants With an ACR 70% Improvement (ACR70) Response
ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of Disease Activity, 3) Participant's Assessment of Pain, 4) Participant's Assessment of Functional Disability via a HAQ, and 5) CRP at each visit.
Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP])
DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count 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) less than or equal to (≤)3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<)2.6 = remission.
Change From Baseline in DAS28-3 (CRP)
DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR])
DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 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 DAS28-4 (ESR)
DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity.
Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement)
DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Percentage of Participants With DAS28-3 (CRP) Score ≤3.2
DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 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.
Percentage of Participants With DAS28-3 (CRP) Score <2.6
DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) <2.6 implied remission.
Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement)
DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Percentage of Participants With DAS28-4 (ESR) ≤3.2
DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity.
Percentage of Participants With DAS28-4 (ESR) <2.6
DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) <2.6 implied remission.

Full Information

First Posted
July 15, 2010
Last Updated
April 21, 2015
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01164579
Brief Title
Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)
Official Title
An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Early Rheumatoid Arthritis, Joint Structure, Magnetic Resonance Imaging, Janus Kinase (JAK) Inhibitor, Tasocitinib, Tofacitinib

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Tofacitinib (CP 690,550) 10 mg BID plus MTX
Arm Type
Experimental
Arm Title
Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX
Arm Type
Experimental
Arm Title
Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tasocitinib plus Methotrexate
Intervention Description
Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months
Intervention Type
Drug
Intervention Name(s)
Tofacitinib plus placebo methotrexate
Intervention Description
Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1.
Intervention Type
Drug
Intervention Name(s)
Placebo tofacitinib plus Methotrexate
Intervention Description
Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib
Primary Outcome Measure Information:
Title
Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis
Description
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
Time Frame
Month 3
Title
Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema
Description
Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis
Description
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
Time Frame
Months 1, 6, and 12
Title
Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP
Description
Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0â€"3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1â€"33% of bone edematous; 2: 34â€"66% of bone edematous; 3: 67â€"100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.
Time Frame
Months 1, 3, and 12
Title
Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions
Description
Bone erosion assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Each site was scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. OMERACT RAMRIS total erosion score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist is 250 (range 0-250). Increasing score=greater severity.
Time Frame
Months 1, 3, 6, and 12
Title
Modified Total Sharp Score (mTSS) at Months 6 and 12
Description
Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame
Months 6 and 12
Title
Change From Baseline to Months 6 and 12 in mTSS
Description
Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) + erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame
Months 6 and 12
Title
Joint Space Narrowing (JSN) Scores at Months 6 and 12
Description
JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame
Months 6 and 12
Title
Change From Baseline to Months 6 and 12 in JSN Scores
Description
JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame
Months 6 and 12
Title
Erosion Scores at Months 6 and 12
Description
Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame
Months 6 and 12
Title
Change From Baseline to Months 6 and 12 in Erosion Score
Description
Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame
Months 6 and 12
Title
Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response
Description
ACR20 response: greater than or equal to (≥)20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Participant's Assessment of Pain; Participant's Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame
Months 1, 2, 3, 6, 9, and 12
Title
Percentage of Participants With an ACR 50% Improvement (ACR50) Response
Description
ACR50 response: ≥ 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of disease activity, 3) Paricipant's Assessment of Pain, 4) Participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.
Time Frame
Months 1, 2, 3, 6, 9, and 12
Title
Percentage of Participants With an ACR 70% Improvement (ACR70) Response
Description
ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of Disease Activity, 3) Participant's Assessment of Pain, 4) Participant's Assessment of Functional Disability via a HAQ, and 5) CRP at each visit.
Time Frame
Months 1, 2, 3, 6, 9, and 12
Title
Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP])
Description
DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count 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) less than or equal to (≤)3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<)2.6 = remission.
Time Frame
Baseline and Months 1, 2, 3, 6, 9, and 12
Title
Change From Baseline in DAS28-3 (CRP)
Description
DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.
Time Frame
Months 1, 2, 3, 6, 9, and 12
Title
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR])
Description
DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 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 and Months 1, 2, 3, 6, 9, and 12
Title
Change From Baseline in DAS28-4 (ESR)
Description
DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity.
Time Frame
Months 1, 2, 3, 6, 9, and 12
Title
Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement)
Description
DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Time Frame
Months 1, 2, 3, 6, 9, and 12
Title
Percentage of Participants With DAS28-3 (CRP) Score ≤3.2
Description
DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 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.
Time Frame
Months 1, 2, 3, 6, 9, and 12
Title
Percentage of Participants With DAS28-3 (CRP) Score <2.6
Description
DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) <2.6 implied remission.
Time Frame
Months 1, 2, 3, 6, 9, and 12
Title
Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement)
Description
DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).
Time Frame
Months 1, 2, 3, 6, 9, and 12
Title
Percentage of Participants With DAS28-4 (ESR) ≤3.2
Description
DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity.
Time Frame
Months 1, 2, 3, 6, 9, and 12
Title
Percentage of Participants With DAS28-4 (ESR) <2.6
Description
DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) <2.6 implied remission.
Time Frame
Months 1, 2, 3, 6, 9, and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with moderate to severe early rheumatoid arthritis (< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive. Exclusion Criteria: Pregnant or lactating patients; Patients with renal or hepatic impairment or other severe or progressing disease; Patients with contraindication to magnetic resonance imaging with gadolinium contrast.
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
ArthroCare, Arthritis Care & Research, PC
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Talbert Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Inland Rheumatology Clinical Trials, Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
DMI Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
St. Petersburg Arthritis Center
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104 5005
Country
United States
Facility Name
Office of John P. Lavery, MD, PA
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Facility Name
OMI - Organización Médica de Investigación
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Saint Dennis Medical Group S.A.
City
Buenos Aires
ZIP/Postal Code
C1034ACO
Country
Argentina
Facility Name
Consultorios Reumatologicos Pampa
City
Buenos Aires
ZIP/Postal Code
C1428DZF
Country
Argentina
Facility Name
Hospital Base Valdivia
City
Valdivia
State/Province
Region XIV
ZIP/Postal Code
5090145
Country
Chile
Facility Name
Consulta Privada Dr. Juan Ignacio Vargas
City
Osorno
State/Province
X Region
ZIP/Postal Code
5311089
Country
Chile
Facility Name
University Hospital Centre Split,Department for Internal Medicine, Division of Clinical Rheumatology
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
General Hospital Sveti Duh
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
ARTMEDI UPD s r.o.
City
Hostivice
ZIP/Postal Code
253 01
Country
Czech Republic
Facility Name
DC Mediscan
City
Praha 11 - Chodov
ZIP/Postal Code
148 00
Country
Czech Republic
Facility Name
Nemocnice na Frantisku s poliklinikou
City
Praha 1
ZIP/Postal Code
110 00
Country
Czech Republic
Facility Name
Nemocnice na Frantisku
City
Praha 1
ZIP/Postal Code
110 00
Country
Czech Republic
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
128 50
Country
Czech Republic
Facility Name
Uherskohradistska nemocnice, a.s.
City
Uherske Hradiste
ZIP/Postal Code
686 68
Country
Czech Republic
Facility Name
Nemocnice Atlas, a.s.
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
Facility Name
PV-Medical s.r.o.
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
Facility Name
Drug Research Center Kft.
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Orszagos Reumatologiai es Fizioterapias Intezet
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Synexus Magyarorszag Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Reumatologiai Tanszek
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz/Reumatologiai es Mozgasszervi Rehabilitacios Centrum
City
Gyor
ZIP/Postal Code
9027
Country
Hungary
Facility Name
Centro de Investigacion y Tratamiento Reumatologico S.C.
City
Mexico
State/Province
D. F.
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Hospital Angeles Mocel
City
Mexico
State/Province
D.f.
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Centro de Investigacion y Tratamiento Reumatologico SC
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Hospital Angeles Mocel
City
Chapultepec
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Investigacion y Biomedicina de Chihuahua S.C
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Hospital Angeles Mocel
City
Mexico D.F.
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Osteoporozy i Chorob Kostno-Stawowych J.
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Nzoz "Nasz Lekarz"
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Mindful Medical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
San Juan Arthritis & Research Center
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
34870800
Citation
Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
Results Reference
derived
PubMed Identifier
33127856
Citation
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
Results Reference
derived
PubMed Identifier
33057725
Citation
van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.
Results Reference
derived
PubMed Identifier
32816215
Citation
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
Results Reference
derived
PubMed Identifier
31639034
Citation
Conaghan PG, Ostergaard M, Troum O, Bowes MA, Guillard G, Wilkinson B, Xie Z, Andrews J, Stein A, Chapman D, Koenig A. Very early MRI responses to therapy as a predictor of later radiographic progression in early rheumatoid arthritis. Arthritis Res Ther. 2019 Oct 21;21(1):214. doi: 10.1186/s13075-019-2000-1.
Results Reference
derived
PubMed Identifier
28143815
Citation
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
Results Reference
derived
PubMed Identifier
27002108
Citation
Conaghan PG, Ostergaard M, Bowes MA, Wu C, Fuerst T, van der Heijde D, Irazoque-Palazuelos F, Soto-Raices O, Hrycaj P, Xie Z, Zhang R, Wyman BT, Bradley JD, Soma K, Wilkinson B. Comparing the effects of tofacitinib, methotrexate and the combination, on bone marrow oedema, synovitis and bone erosion in methotrexate-naive, early active rheumatoid arthritis: results of an exploratory randomised MRI study incorporating semiquantitative and quantitative techniques. Ann Rheum Dis. 2016 Jun;75(6):1024-33. doi: 10.1136/annrheumdis-2015-208267. Epub 2016 Jan 25.
Results Reference
derived
PubMed Identifier
25047021
Citation
Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921068&StudyName=Effects%20of%20Tofacitinib%20%28CP-690%2C550%29%20on%20Magnetic%20Resonance%20Imaging%20%28MRI%29-%20Assessed%20Joint%20Structure%20In%20Early%20Rheumatoid%20Arthritis%20%28R
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

We'll reach out to this number within 24 hrs