A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

Part of paid clinical trials in Sun City, Arizona.

Sponsor
AbbVie
Study ID
NCT02814175
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week 32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment regimens using adalimumab and/or MTX, with participant allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.

Key Dates

Start date
Aug 5, 2016
Status verified
Oct 2020
Primary completion
Sep 23, 2019
Completion
Mar 19, 2020

Study Design

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

Arms

  • Active Comparator: Part 1: MTX Escalated Dose
    Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)
  • Experimental: Part 1: ADA + MTX
    Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew
  • Active Comparator: Part 2: MTX Escalated Dose
    Participants achieving minimal disease activity (MDA) at Week 16 on MTX escalated to 20 -25 mg or highest tolerable dose ew, continued with the same MTX dose
  • Active Comparator: Part 2: ADA + MTX Escalated Dose
    Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received ADA 40 mg eow in combination with MTX 20 - 25 mg or highest tolerable dose ew
  • Experimental: Part 2: ADA
    Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy
  • Experimental: Part 2: ADA ew + MTX
    Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew

Primary Outcome Measure

Percentage of Participants Achieving Minimal Disease Activity (MDA) (Non-responder Imputation [NRI]) (Part 1) [ Time Frame: Week 16 ]

Locations (12)

FacilityCityStateZIPSite coordinators
AZ Arthritis & Rheum Research /ID# 161796Sun CityArizona85351-
LeJenue Research Associates /ID# 200093MiamiFlorida33126-
Deerbrook Medical Associates /ID# 158655Vernon HillsIllinois60061-
Ochsner Clinic Foundation /ID# 155178Baton RougeLouisiana70836-6455-
Clinical Pharmacology Study Gr /ID# 161057WorcesterMassachusetts01605-
Shores Rheumatology, PC /ID# 162697Saint Clair ShoresMichigan48081-
Coastal Carolina Health Care /ID# 152088New BernNorth Carolina28562-
PMG Research of Wilmington LLC /ID# 152089WilmingtonNorth Carolina28401-
Altoona Ctr Clinical Res /ID# 152087DuncansvillePennsylvania16635-
Metroplex Clinical Research /ID# 162486DallasTexas75231-
Swedish Medical Center /ID# 162051SeattleWashington98104-
West Virginia Research Inst /ID# 157815South CharlestonWest Virginia25309-

Find similar trials in Sun City, AZ

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
AZ Arthritis & Rheum Research· Sun City, AZLeJenue Research Associates· Miami, FLDeerbrook Medical Associates· Vernon Hills, ILOchsner Clinic Foundation· Baton Rouge, LAClinical Pharmacology Study Gr· Worcester, MAShores Rheumatology, PC· Saint Clair Shores, MI

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