A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
AbbVie
Study ID
NCT02198651
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — BIOLOGICAL
    Pre-filled syringe, administered by subcutaneous injection
  • Placebo — OTHER
    Pre-filled syringe, administered by subcutaneous injection in the Double-blind period

Study Details

The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.

Key Dates

Start date
Jan 5, 2015
Status verified
Jun 2019
Primary completion
May 3, 2018
Completion
Aug 8, 2018

Study Design

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

Arms

  • Experimental: Adalimumab 40 mg eow
    40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 (Lead-in Period)
  • Active Comparator: Adalimumab Tapering
    40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
  • Placebo Comparator: Adalimumab Withdrawal Arm
    Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)
  • Experimental: Adalimumab 40 mg eow Rescue Arm
    40 mg adalimumab administered subcutaneously every other week from Flare Week 0 to Flare Week 16 (Open-label Rescue Period)

Primary Outcome Measure

Association Between Baseline Hand and Wrist Synovitis Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score and Flare up to Week 40 in the Tapering Arm [ Time Frame: From Week 4 to Week 40 ]

Locations (13)

FacilityCityStateZIPSite coordinators
J Michael Grelier Research /ID# 149772TuscaloosaAlabama35406-
Westlake Medical Research (WMR) Clinical Trials /ID# 155386Thousand OaksCalifornia91360-3994-
University of Florida /ID# 144851JacksonvilleFlorida32209-
North Georgia Rheumatology Grp /ID# 155225LawrencevilleGeorgia30045-
The Arthritis & Diabetes Clinic, Inc. /ID# 149017MonroeLouisiana71203-
Aa Mrc Llc /Id# 151933Grand BlancMichigan48439-
North Mississippi Med Clinics /ID# 149443TupeloMississippi38801-
Montefiore Medical Center /ID# 155013The BronxNew York10461-
Shanahan Rheuma & Immuno /ID# 148689RaleighNorth Carolina27617-
Altoona Ctr Clinical Res /ID# 148448DuncansvillePennsylvania16635-
Low Country Rheumatology, PA /ID# 154198SummervilleSouth Carolina29486-
West Tennessee Research Inst /ID# 148391JacksonTennessee38305-
Arthritis Centers of Texas /ID# 152843DallasTexas75246-

Find similar trials in Tuscaloosa, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
J Michael Grelier Research· Tuscaloosa, ALWestlake Medical Research (WMR) Clinical Trials· Thousand Oaks, CAUniversity of Florida· Jacksonville, FLNorth Georgia Rheumatology Grp· Lawrenceville, GAThe Arthritis & Diabetes Clinic, Inc.· Monroe, LAAa Mrc Llc· Grand Blanc, MI

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