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)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01185288
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — BIOLOGICAL
    Adalimumab in pre-filled syringes
  • Methotrexate — DRUG
    Methotrexate capsule

Study Details

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).

Key Dates

Start date
Sep 30, 2010
Status verified
Jan 2014
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013

Study Design

Enrollment
309 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab + Low Dose Methotrexate
    Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
  • Active Comparator: Adalimumab + High Dose Methotrexate
    Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).

Primary Outcome Measure

Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24 [ Time Frame: Week 24 ]

Locations (46)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 38982HuntsvilleAlabama35801-
Site Reference ID/Investigator# 38686TuscaloosaAlabama35406-
Site Reference ID/Investigator# 42044MesaArizona85202-
Site Reference ID/Investigator# 37983PhoenixArizona85031-
Site Reference ID/Investigator# 44823Little RockArkansas72205-
Site Reference ID/Investigator# 37981HemetCalifornia92543-
Site Reference ID/Investigator# 40208Long BeachCalifornia90822-
Site Reference ID/Investigator# 38423SacramentoCalifornia95816-
Site Reference ID/Investigator# 38204VictorvilleCalifornia92395-
Site Reference ID/Investigator# 40762Walnut CreekCalifornia94598-
Site Reference ID/Investigator# 43049DanburyConnecticut06810-
Site Reference ID/Investigator# 38687JacksonvilleFlorida32209-
Site Reference ID/Investigator# 40105MiamiFlorida33169-
Site Reference ID/Investigator# 38083SarasotaFlorida34239-
Site Reference ID/Investigator# 38688LawrencevilleGeorgia30045-
Site Reference ID/Investigator# 38689MeridianIdaho83642-
Site Reference ID/Investigator# 38085Rock IslandIllinois61201-
Site Reference ID/Investigator# 40128SpringfieldIllinois62704-
Site Reference ID/Investigator# 38981Bowling GreenKentucky42101-
Site Reference ID/Investigator# 38086CovingtonLouisiana70433-
Site Reference ID/Investigator# 40125Fall RiverMassachusetts02720-
Site Reference ID/Investigator# 65490Las VegasNevada89102-
Site Reference ID/Investigator# 40124CliftonNew Jersey07012-
Site Reference ID/Investigator# 38978FreeholdNew Jersey07728-
Site Reference ID/Investigator# 40123Voorhees TownshipNew Jersey08043-
Site Reference ID/Investigator# 38264SmithtownNew York11787-
Site Reference ID/Investigator# 38983The BronxNew York10467-
Site Reference ID/Investigator# 38263AshevilleNorth Carolina28803-
Site Reference ID/Investigator# 38261GreenvilleNorth Carolina27834-
Site Reference ID/Investigator# 39024Mayfield VillageOhio44143-
Site Reference ID/Investigator# 40127Oklahoma CityOklahoma73104-
Site Reference ID/Investigator# 38202BendOregon97701-
Site Reference ID/Investigator# 39023EugeneOregon97401-
Site Reference ID/Investigator# 38265DuncansvillePennsylvania16635-
Site Reference ID/Investigator# 38082JacksonTennessee38305-
Site Reference ID/Investigator# 37980DallasTexas75231-
Site Reference ID/Investigator# 44888DallasTexas75246-
Site Reference ID/Investigator# 43050HoustonTexas77074-
Site Reference ID/Investigator# 43735San AntonioTexas78229-
Site Reference ID/Investigator# 44344RichmondVirginia23294-
Site Reference ID/Investigator# 38084SeattleWashington98122-
Site Reference ID/Investigator# 38542SeattleWashington98133-
Site Reference ID/Investigator# 40210SeattleWashington98101-
Site Reference ID/Investigator# 38424SpokaneWashington99204-
Site Reference ID/Investigator# 38203TacomaWashington98405-
Site Reference ID/Investigator# 38087FranklinWisconsin53132-

Find similar trials in Huntsville, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Site Reference ID/Investigator# 38982· Huntsville, ALSite Reference ID/Investigator# 38686· Tuscaloosa, ALSite Reference ID/Investigator# 42044· Mesa, AZSite Reference ID/Investigator# 37983· Phoenix, AZSite Reference ID/Investigator# 44823· Little Rock, ARSite Reference ID/Investigator# 37981· Hemet, CA

Related Studies