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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis (RA)

In brief

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 facts

Study ID

NCT03823391

Run by

AbbVie

People needed

48

Starts

2019-03-27

Expected to finish

2020-08-26

Last updated by the study team

2021-07-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has the clinical diagnosis of RA for > 3 months based on the 1987 American College of Rheumatology (ACR) classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria.
• Participant meets the following disease activity criteria: >= 4 swollen joints (based on 28 joint count) and >= 4 tender joints (based on 28 joint count) at Screening and Baseline visits and disease activity score (28 joints) (DAS28) C-reactive protein (CRP) >= 3.2 at Screening.
• Participant has an incomplete response to methotrexate. Participants must have been on oral or parental MTX therapy >= 3 months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. Participant must be expected to be able to continue on stable dose of MTX for the duration of study participation.

You may not qualify if…

• Participants previously exposed to adalimumab or other anti-tumor necrosis factor (TNF) biologics.
• Participants previously exposed to non-anti-TNF biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for RA, with exception of participants exposed for less than 3 months and terminated not due to lack of efficacy or intolerability.

Where it is running

• Rheum Assoc of North Alabama /ID# 213626 — Huntsville, Alabama, United States
• AZ Arthritis and Rheum Researc /ID# 208515 — Phoenix, Arizona, United States
• C.V. Mehta MD, Med Corporation /ID# 213068 — Hemet, California, United States
• Robin K. Dore MD, Inc /ID# 213045 — Tustin, California, United States
• Inland Rheum & Osteo Med Grp /ID# 213044 — Upland, California, United States
• Suncoast Clinical Research /ID# 213973 — New Port Richey, Florida, United States
• Arthritis Center, Inc. /ID# 213972 — Palm Harbor, Florida, United States
• W. Broward Rheum Assoc Inc. /ID# 211017 — Tamarac, Florida, United States
• BayCare Medical Group, Inc. /ID# 213935 — Tampa, Florida, United States
• Institute of Arthritis Researc /ID# 213043 — Idaho Falls, Idaho, United States
• PRN Professional Research Network of Kansas, LLC /ID# 213046 — Wichita, Kansas, United States
• Clinvest Research LLC /ID# 215451 — Springfield, Missouri, United States
• Duke Early Phase Research Unit (DCRI) /ID# 213212 — Durham, North Carolina, United States
• Paramount Medical Research Con /ID# 209042 — Middleburg Heights, Ohio, United States
• STAT Research, Inc. /ID# 213933 — Vandalia, Ohio, United States
• West Tennessee Research Inst /ID# 208838 — Jackson, Tennessee, United States
• PCCR Solution /ID# 215457 — Colleyville, Texas, United States
• Trinity Universal Research Association /ID# 209167 — Plano, Texas, United States
• Charite Research Organisation GmbH /ID# 210216 — Berlin, Germany
• CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 210055 — Miskolc, Borsod-Abauj Zemplen county, Hungary
• DRC Gyogyszervizsgalo Kozpont Kft. /ID# 210159 — Balatonfüred, Veszprém megye, Hungary
• Budai Irgalmasrendi Korhaz /ID# 208877 — Budapest, Hungary
• Debreceni Egyetem Klinikai Kozpont /ID# 210164 — Debrecen, Hungary
• Rambam Health Care Campus /ID# 212747 — Haifa, Israel
• Sheba Medical Center /ID# 211339 — Ramat Gan, Israel

Full record on ClinicalTrials.gov

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