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Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis
NCT05814627 · View on ClinicalTrials.gov ↗
Study Summary
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Conditions Studied
Interventions
- DRUG Adalimumab
- DRUG Upadacitinib
- DRUG Upadacitinib Matching Placebo
- DRUG Adalimumab Matching Placebo
Study Locations (20)
California
- Providence - St. Jude Medical Center /ID# 252690 — Fullerton
- Newport Huntington Medical Group /ID# 252687 — Huntington Beach
- Purushotham & Akther Kotha MD, Inc /ID# 252704 — La Mesa
- Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692 — Los Alamitos
- Rheumatology Center of San Diego /ID# 255038 — San Diego
- Millennium Clinical Trials /ID# 252689 — Thousand Oaks
- The Lundquist Institute at Harbor-UCLA Medical Center /ID# 252691 — Torrance
- Comprehensive Rheumatology Center /ID# 252688 — Woodland Hills
Arizona
- AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431 — Flagstaff
- Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018 — Glendale
- Sun Valley Arthritis Center Ltd. /ID# 254654 — Peoria
- Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 253432 — Phoenix
- Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 255021 — Phoenix
- Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017 — Tucson
Colorado
- University of Colorado Hospital /ID# 254617 — Aurora
- Denver Arthritis Clinic /ID# 254058 — Denver
- Tekton Research - Fort Collins - East Harmony Road /ID# 255036 — Fort Collins
Florida
- Arthritis and Rheumatic Disease Specialties /ID# 260583 — Aventura
- Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733 — Boca Raton
Arkansas
- Arthritis and Rheumatism Associates /ID# 254013 — Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 487 participants |
| Start Date | 2023-06-15 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05814627
The ClinicalTrials.gov registry entry for NCT05814627 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 487 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions — of which Adalimumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05814627 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05814627 about?
NCT05814627 is a clinical study titled "Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis". Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-...
What is the current status of trial NCT05814627?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 487 participants. The study started on 2023-06-15. Estimated completion is 2026-07.
What conditions does trial NCT05814627 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05814627?
The interventions under investigation include: Adalimumab (DRUG), Upadacitinib (DRUG), Upadacitinib Matching Placebo (DRUG), Adalimumab Matching Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05814627?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05814627 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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