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A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA) (MUSICA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Adalimumab
Methotrexate
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Adult subjects with moderately to severely active rheumatoid arthritis
  • Subjects must have a DAS28(CRP) (Disease Activity Score using C-Reactive Protein) greater than or equal to 3.2 at baseline (there is no minimum CRP score required to qualify)
  • Subjects must have at least 5/68 tender joints plus 5/66 swollen joints assessed at screening or baseline
  • Subject must treated with and MTX (methotrexate) dose (oral and/or injectable) of 15 mg or more per week (no upper limit on dose) for at least 12 weeks prior to screening
  • Subject is either biologic-naïve or has only one prior biologic disease-modifying antirheumatic drug (i.e. abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, or tocilizumab)

Exclusion Criteria:

  • Previous exposure to adalimumab (Humira), rituximab (Rituxan), natalizumab (Tysabri), efalizumab (Raptiva)
  • Subject has been treated with intra-articular or parenteral administration of corticosteroids within 4 weeks of screening
  • Subject has diagnosis or history of gout or pseudogout
  • Subject has undergone joint surgery within 12 weeks of screening (at joints to be assessed by ultrasound)
  • Subject has history of chronic arthritis diagnosed before age 16 years

Sites / Locations

  • Site Reference ID/Investigator# 38982
  • Site Reference ID/Investigator# 38686
  • Site Reference ID/Investigator# 42044
  • Site Reference ID/Investigator# 37983
  • Site Reference ID/Investigator# 44823
  • Site Reference ID/Investigator# 37981
  • Site Reference ID/Investigator# 40208
  • Site Reference ID/Investigator# 38423
  • Site Reference ID/Investigator# 38204
  • Site Reference ID/Investigator# 40762
  • Site Reference ID/Investigator# 43049
  • Site Reference ID/Investigator# 38687
  • Site Reference ID/Investigator# 40105
  • Site Reference ID/Investigator# 38083
  • Site Reference ID/Investigator# 38688
  • Site Reference ID/Investigator# 38689
  • Site Reference ID/Investigator# 38085
  • Site Reference ID/Investigator# 40128
  • Site Reference ID/Investigator# 38981
  • Site Reference ID/Investigator# 38086
  • Site Reference ID/Investigator# 40125
  • Site Reference ID/Investigator# 65490
  • Site Reference ID/Investigator# 40124
  • Site Reference ID/Investigator# 38978
  • Site Reference ID/Investigator# 40123
  • Site Reference ID/Investigator# 38983
  • Site Reference ID/Investigator# 38264
  • Site Reference ID/Investigator# 38263
  • Site Reference ID/Investigator# 38261
  • Site Reference ID/Investigator# 39024
  • Site Reference ID/Investigator# 40127
  • Site Reference ID/Investigator# 38202
  • Site Reference ID/Investigator# 39023
  • Site Reference ID/Investigator# 38265
  • Site Reference ID/Investigator# 38082
  • Site Reference ID/Investigator# 37980
  • Site Reference ID/Investigator# 44888
  • Site Reference ID/Investigator# 43050
  • Site Reference ID/Investigator# 43735
  • Site Reference ID/Investigator# 44344
  • Site Reference ID/Investigator# 40210
  • Site Reference ID/Investigator# 38084
  • Site Reference ID/Investigator# 38542
  • Site Reference ID/Investigator# 38424
  • Site Reference ID/Investigator# 38203
  • Site Reference ID/Investigator# 38087
  • Site Reference ID/Investigator# 60850
  • Site Reference ID/Investigator# 38691
  • Site Reference ID/Investigator# 60851

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adalimumab + Low Dose Methotrexate

Adalimumab + High Dose Methotrexate

Arm Description

Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).

Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).

Outcomes

Primary Outcome Measures

Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24
The DAS28(CRP) score includes 28 tender joint counts, 28 swollen joint counts, C-reactive protein, and participant's global assessment of disease activity. Scores on the DAS28(CRP) range from 0 to 10. A DAS28(CRP) score ≥ 5.1 indicates high disease activity, and a DAS28(CRP) score < 2.6 indicates clinical remission. Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline DAS28(CRP) value, treatment group, and prior methotrexate dose group.

Secondary Outcome Measures

Percentage of Participants With Power Doppler Ultrasound (PD U/S) Score for Synovial Vascularity Improvement by 30% at Week 24
PD U/S assessed the severity of synovial inflammation in both hands (bilateral wrists, metacarpophalangeal joints 2, 3, 5, and metatarsophalangeal joint 5). Bilateral images based on dorsal midline imaging of the wrist, dorsal and volar imaging of metacarpophalangeal joints, and dorsal imaging alone of metatarsophalangeal joints are scored using a 4-grade scale: grade 0 or normal = normal joint (no Doppler signal); grade 1 or mild = mild synovitis (≤ 3 isolated signals); grade 2 or moderate = moderate synovitis (> 3 isolated signals or a confluent signal in < 50% of synovial area); grade 3 or marked = marked synovitis (signals in ≥ 50% of the synovial area). Each image is rated 0 to 3, for a total possible score ranging from 0 to 48 (16*0, 16*3) for 2 hands. Higher grade/score=more severe disease. Change = week 24 score - baseline score.
Percentage of Participants With American College of Rheumatology 50% (ACR50) Criteria Response at Week 24
Response, as defined by ACR50 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).
Percentage of Participants With American College of Rheumatology 70% (ACR70) Criteria Response at Week 24
Response, as defined by ACR70 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).
Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤ -0.22 at Week 24
The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high dependency disability). The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from baseline of ≤ -0.22. Normal physical function is defined by HAQ-DI score of < 0.5. Negative change from baseline in the overall score indicates improvement.
Percent Change From Baseline in Medical Outcomes Study Version II (MOS) Sleep Problem Index 9 at Week 24
The least squares mean percentage change in MOS Sleep Problem Index 9 from baseline to week 24. The MOS Sleep Problem Index 9 consists of 9 questions to assess sleep, including how long it takes the participant to fall asleep (1=0 to 15 minutes, to 5=more than 60 minutes); and aspects of related to quality of sleep, including how often the participant felt that the sleep was not quiet, felt rested upon waking, awakened short of breath or with a headache, felt drowsy during the day, had trouble falling sleep, how often were awaken, had trouble staying awake during the day, and got needed amount of sleep (1=all the time; 5=none of the time). Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline MOS Sleep Problem Index value, treatment group, and prior methotrexate dose group.

Full Information

First Posted
August 18, 2010
Last Updated
January 31, 2014
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01185288
Brief Title
A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)
Acronym
MUSICA
Official Title
A Multicenter, Double-Blind, Randomized, Parallel-Arm Study to Determine the Effect of Methotrexate Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis Treated With Adalimumab (MUSICA)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in combination with open-label adalimumab (ADA) in patients who have had an inadequate response to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two regimens of MTX in combination with ADA in participants with rheumatoid arthritis (RA).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab + Low Dose Methotrexate
Arm Type
Experimental
Arm Description
Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
Arm Title
Adalimumab + High Dose Methotrexate
Arm Type
Active Comparator
Arm Description
Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
Adalimumab in pre-filled syringes
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate capsule
Primary Outcome Measure Information:
Title
Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24
Description
The DAS28(CRP) score includes 28 tender joint counts, 28 swollen joint counts, C-reactive protein, and participant's global assessment of disease activity. Scores on the DAS28(CRP) range from 0 to 10. A DAS28(CRP) score ≥ 5.1 indicates high disease activity, and a DAS28(CRP) score < 2.6 indicates clinical remission. Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline DAS28(CRP) value, treatment group, and prior methotrexate dose group.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With Power Doppler Ultrasound (PD U/S) Score for Synovial Vascularity Improvement by 30% at Week 24
Description
PD U/S assessed the severity of synovial inflammation in both hands (bilateral wrists, metacarpophalangeal joints 2, 3, 5, and metatarsophalangeal joint 5). Bilateral images based on dorsal midline imaging of the wrist, dorsal and volar imaging of metacarpophalangeal joints, and dorsal imaging alone of metatarsophalangeal joints are scored using a 4-grade scale: grade 0 or normal = normal joint (no Doppler signal); grade 1 or mild = mild synovitis (≤ 3 isolated signals); grade 2 or moderate = moderate synovitis (> 3 isolated signals or a confluent signal in < 50% of synovial area); grade 3 or marked = marked synovitis (signals in ≥ 50% of the synovial area). Each image is rated 0 to 3, for a total possible score ranging from 0 to 48 (16*0, 16*3) for 2 hands. Higher grade/score=more severe disease. Change = week 24 score - baseline score.
Time Frame
Baseline, 24 weeks
Title
Percentage of Participants With American College of Rheumatology 50% (ACR50) Criteria Response at Week 24
Description
Response, as defined by ACR50 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).
Time Frame
Baseline, 24 weeks
Title
Percentage of Participants With American College of Rheumatology 70% (ACR70) Criteria Response at Week 24
Description
Response, as defined by ACR70 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).
Time Frame
Baseline, 24 weeks
Title
Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤ -0.22 at Week 24
Description
The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high dependency disability). The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from baseline of ≤ -0.22. Normal physical function is defined by HAQ-DI score of < 0.5. Negative change from baseline in the overall score indicates improvement.
Time Frame
Baseline, 24 weeks
Title
Percent Change From Baseline in Medical Outcomes Study Version II (MOS) Sleep Problem Index 9 at Week 24
Description
The least squares mean percentage change in MOS Sleep Problem Index 9 from baseline to week 24. The MOS Sleep Problem Index 9 consists of 9 questions to assess sleep, including how long it takes the participant to fall asleep (1=0 to 15 minutes, to 5=more than 60 minutes); and aspects of related to quality of sleep, including how often the participant felt that the sleep was not quiet, felt rested upon waking, awakened short of breath or with a headache, felt drowsy during the day, had trouble falling sleep, how often were awaken, had trouble staying awake during the day, and got needed amount of sleep (1=all the time; 5=none of the time). Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline MOS Sleep Problem Index value, treatment group, and prior methotrexate dose group.
Time Frame
Baseline, 24 weeks
Other Pre-specified Outcome Measures:
Title
Serum Adalimumab Trough Concentrations at Week 24
Description
Serum trough concentrations of adalimumab assessed at week 24 (24 weeks after the 1st dose).
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult subjects with moderately to severely active rheumatoid arthritis Subjects must have a DAS28(CRP) (Disease Activity Score using C-Reactive Protein) greater than or equal to 3.2 at baseline (there is no minimum CRP score required to qualify) Subjects must have at least 5/68 tender joints plus 5/66 swollen joints assessed at screening or baseline Subject must treated with and MTX (methotrexate) dose (oral and/or injectable) of 15 mg or more per week (no upper limit on dose) for at least 12 weeks prior to screening Subject is either biologic-naïve or has only one prior biologic disease-modifying antirheumatic drug (i.e. abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, or tocilizumab) Exclusion Criteria: Previous exposure to adalimumab (Humira), rituximab (Rituxan), natalizumab (Tysabri), efalizumab (Raptiva) Subject has been treated with intra-articular or parenteral administration of corticosteroids within 4 weeks of screening Subject has diagnosis or history of gout or pseudogout Subject has undergone joint surgery within 12 weeks of screening (at joints to be assessed by ultrasound) Subject has history of chronic arthritis diagnosed before age 16 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Carlson, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 38982
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Site Reference ID/Investigator# 38686
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Site Reference ID/Investigator# 42044
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Site Reference ID/Investigator# 37983
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85031
Country
United States
Facility Name
Site Reference ID/Investigator# 44823
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Site Reference ID/Investigator# 37981
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Site Reference ID/Investigator# 40208
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Site Reference ID/Investigator# 38423
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Site Reference ID/Investigator# 38204
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Facility Name
Site Reference ID/Investigator# 40762
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Site Reference ID/Investigator# 43049
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Site Reference ID/Investigator# 38687
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Site Reference ID/Investigator# 40105
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Site Reference ID/Investigator# 38083
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Site Reference ID/Investigator# 38688
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Site Reference ID/Investigator# 38689
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Site Reference ID/Investigator# 38085
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Facility Name
Site Reference ID/Investigator# 40128
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Site Reference ID/Investigator# 38981
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Site Reference ID/Investigator# 38086
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Site Reference ID/Investigator# 40125
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Site Reference ID/Investigator# 65490
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Site Reference ID/Investigator# 40124
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
Facility Name
Site Reference ID/Investigator# 38978
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Site Reference ID/Investigator# 40123
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Site Reference ID/Investigator# 38983
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Site Reference ID/Investigator# 38264
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Site Reference ID/Investigator# 38263
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Site Reference ID/Investigator# 38261
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Site Reference ID/Investigator# 39024
City
Mayfield Village
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
Facility Name
Site Reference ID/Investigator# 40127
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Site Reference ID/Investigator# 38202
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Site Reference ID/Investigator# 39023
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Site Reference ID/Investigator# 38265
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site Reference ID/Investigator# 38082
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Site Reference ID/Investigator# 37980
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site Reference ID/Investigator# 44888
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Site Reference ID/Investigator# 43050
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Site Reference ID/Investigator# 43735
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 44344
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Site Reference ID/Investigator# 40210
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Site Reference ID/Investigator# 38084
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Site Reference ID/Investigator# 38542
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Site Reference ID/Investigator# 38424
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Site Reference ID/Investigator# 38203
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Site Reference ID/Investigator# 38087
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
Site Reference ID/Investigator# 60850
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 38691
City
San Juan
ZIP/Postal Code
00936-8344
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 60851
City
Vega Baja
ZIP/Postal Code
00694-0764
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
30173153
Citation
Kaeley GS, MacCarter DK, Pangan AL, Wang X, Kalabic J, Ranganath VK. Clinical Responses and Synovial Vascularity in Obese Rheumatoid Arthritis Patients Treated with Adalimumab and Methotrexate. J Rheumatol. 2018 Dec;45(12):1628-1635. doi: 10.3899/jrheum.171232. Epub 2018 Sep 1.
Results Reference
derived
PubMed Identifier
29574622
Citation
Kaeley GS, MacCarter DK, Goyal JR, Liu S, Chen K, Griffith J, Kupper H, Garg V, Kalabic J. Similar Improvements in Patient-Reported Outcomes Among Rheumatoid Arthritis Patients Treated with Two Different Doses of Methotrexate in Combination with Adalimumab: Results From the MUSICA Trial. Rheumatol Ther. 2018 Jun;5(1):123-134. doi: 10.1007/s40744-018-0105-7. Epub 2018 Mar 24.
Results Reference
derived
PubMed Identifier
28955494
Citation
Burmester GR, Kaeley GS, Kavanaugh AF, Gabay C, MacCarter DK, Nash P, Takeuchi T, Goss SL, Rodila R, Chen K, Kupper H, Kalabic J. Treatment efficacy and methotrexate-related toxicity in patients with rheumatoid arthritis receiving methotrexate in combination with adalimumab. RMD Open. 2017 Sep 17;3(2):e000465. doi: 10.1136/rmdopen-2017-000465. eCollection 2017.
Results Reference
derived
PubMed Identifier
27214046
Citation
Kaeley GS, Nishio MJ, Goyal JR, MacCarter DK, Wells AF, Chen S, Kupper H, Kalabic J. Changes in Ultrasonographic Vascularity Upon Initiation of Adalimumab Combination Therapy in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2016 Nov;68(11):2584-2592. doi: 10.1002/art.39751. Epub 2016 Sep 29.
Results Reference
derived
PubMed Identifier
27338778
Citation
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Results Reference
derived
PubMed Identifier
27307526
Citation
Kaeley GS, Evangelisto AM, Nishio MJ, Goss SL, Liu S, Kalabic J, Kupper H. Methotrexate Dosage Reduction Upon Adalimumab Initiation: Clinical and Ultrasonographic Outcomes from the Randomized Noninferiority MUSICA Trial. J Rheumatol. 2016 Aug;43(8):1480-9. doi: 10.3899/jrheum.151009. Epub 2016 Jun 15.
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http://rxabbvie.com
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A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)

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