A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AbbVie
Study ID
NCT03823391
Phase
PHASE2
Status
Completed

Conditions

  • Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ABBV-3373 — DRUG
    ABBV-3373 is administered as intravenous (IV) infusion
  • Placebo for ABBV-3373 — DRUG
    Placebo for ABBV-3373 is administered as IV infusion
  • Adalimumab — DRUG
    Adalimumab is administered as subcutaneous (SC) injection
  • Placebo for adalimumab — DRUG
    Placebo for adalimumab is administered as subcutaneous (SC) injection

Study Details

This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.

Key Dates

Start date
Mar 27, 2019
Status verified
Jun 2021
Primary completion
Apr 8, 2020
Completion
Aug 26, 2020

Study Design

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

Arms

  • Experimental: ABBV-3373 Followed by Placebo
    Participants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22.
  • Experimental: Adalimumab
    Participants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22.

Primary Outcome Measure

Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP]) [ Time Frame: Baseline and Week 12 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Rheum Assoc of North Alabama /ID# 213626HuntsvilleAlabama35801-
AZ Arthritis and Rheum Researc /ID# 208515PhoenixArizona85032-
C.V. Mehta MD, Med Corporation /ID# 213068HemetCalifornia92543-
Robin K. Dore MD, Inc /ID# 213045TustinCalifornia92780-
Inland Rheum & Osteo Med Grp /ID# 213044UplandCalifornia91786-
Suncoast Clinical Research /ID# 213973New Port RicheyFlorida34652-
Arthritis Center, Inc. /ID# 213972Palm HarborFlorida34684-
W. Broward Rheum Assoc Inc. /ID# 211017TamaracFlorida33321-
BayCare Medical Group, Inc. /ID# 213935TampaFlorida33614-7101-
Institute of Arthritis Researc /ID# 213043Idaho FallsIdaho83404-
PRN Professional Research Network of Kansas, LLC /ID# 213046WichitaKansas67205-
Clinvest Research LLC /ID# 215451SpringfieldMissouri65810-2607-
Duke Early Phase Research Unit (DCRI) /ID# 213212DurhamNorth Carolina27710-
Paramount Medical Research Con /ID# 209042Middleburg HeightsOhio44130-
STAT Research, Inc. /ID# 213933VandaliaOhio45377-9464-
West Tennessee Research Inst /ID# 208838JacksonTennessee38305-
PCCR Solution /ID# 215457ColleyvilleTexas76034-
Trinity Universal Research Association /ID# 209167PlanoTexas75024-5283-

Find similar trials in Huntsville, AL

By research site
Rheum Assoc of North Alabama· Huntsville, ALAZ Arthritis and Rheum Researc· Phoenix, AZC.V. Mehta MD, Med Corporation· Hemet, CARobin K. Dore MD, Inc· Tustin, CAInland Rheum & Osteo Med Grp· Upland, CASuncoast Clinical Research· New Port Richey, FL

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