A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
Recruiting · NCT06972446 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- At any time prior to the Screening Visit, participant must have been treated for \> or = 3 months with at least 1 b/tsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/tsDMARD is 2.
- Participant must be on a stable dose of methotrexate (MTX)
Exclusion criteria
- Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit.
- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.
Where it is running
60 locations listed across 19 US states.
- Sun Valley Arthritis Center /ID# 278331 - Peoria, Arizona, United States
- Arensia Research Clinic /ID# 280896 - Phoenix, Arizona, United States
- Arthritis And Rheumatism Associates (Ara) - Jonesboro /ID# 272896 - Jonesboro, Arkansas, United States
- Private Practice - Dr. David S. Hallegua /ID# 277608 - Beverly Hills, California, United States
- Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826 - Chula Vista, California, United States
- Newport Huntington Medical Group /ID# 272439 - Huntington Beach, California, United States
- Cohen Medical Centers /ID# 278341 - Thousand Oaks, California, United States
- The Lundquist Institute /ID# 272481 - Torrance, California, United States
- Inland Rheumatology and Osteoporosis Medical Group /ID# 272449 - Upland, California, United States
- Tekton Research - Fort Collins - East Harmony Road /ID# 272472 - Fort Collins, Colorado, United States
- Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298 - Avon Park, Florida, United States
- Clinical Research Of West Florida - Phase I Unit /ID# 272428 - Clearwater, Florida, United States
- Finlay Medical Research - Greenacres /ID# 281654 - Greenacres City, Florida, United States
- Neoclinical Research - Hialeah /ID# 272070 - Hialeah, Florida, United States
- South Florida Rheumatology /ID# 278339 - Hollywood, Florida, United States
- Swati Shah, MD Rheumatology /ID# 273624 - Jacksonville, Florida, United States
- Life Clinical Trials - Colonial Drive - Margate /ID# 272589 - Margate, Florida, United States
- LeJenue Research Associates /ID# 272269 - Miami, Florida, United States
- HMD Research LLC /ID# 272432 - Orlando, Florida, United States
- Vitalia Research /ID# 272478 - Palm Beach Gardens, Florida, United States
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755 - Tampa, Florida, United States
- Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422 - Chicago, Illinois, United States
- Deerbrook Medical Associates /ID# 273439 - Libertyville, Illinois, United States
- Advanced Quality Medical Research /ID# 277824 - Orland Park, Illinois, United States
- Arnold Arthritis & Rheumatology /ID# 278354 - Skokie, Illinois, United States
- Willow Rheumatology and Wellness /ID# 272691 - Willowbrook, Illinois, United States
- Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650 - Lake Charles, Louisiana, United States
- AA Medical Research Center - Grand Blanc /ID# 272496 - Grand Blanc, Michigan, United States
- Sahni Rheumatology & Therapy /ID# 278352 - West Long Branch, New Jersey, United States
- Albuquerque Center For Rheumatology /ID# 272301 - Albuquerque, New Mexico, United States
- Northwell Health Physician Partners Rheumatology At Great Neck /ID# 275621 - Great Neck, New York, United States
- Joint And Muscle Research Institute /ID# 277290 - Charlotte, North Carolina, United States
- DJL Clinical Research - Charlotte /ID# 272387 - Charlotte, North Carolina, United States
- Cape Fear Arthritis Care /ID# 272076 - Leland, North Carolina, United States
- Paramount Medical Research and Consulting /ID# 272474 - Middleburg Heights, Ohio, United States
- Altoona Center For Clinical Research /ID# 272479 - Duncansville, Pennsylvania, United States
- Low Country Rheumatology /ID# 277607 - Summerville, South Carolina, United States
- West Tennessee Research Institute /ID# 272453 - Jackson, Tennessee, United States
- Arthritis and Rheumatology Research Institute /ID# 272299 - Allen, Texas, United States
- Tekton Research - West Gate /ID# 272270 - Austin, Texas, United States
- Trinity Universal Research Associates - Carrollton /ID# 272577 - Carrollton, Texas, United States
- Arthritis Care Of Texas /ID# 277961 - Corpus Christi, Texas, United States
- Accurate Clinical Research - Houston /ID# 272271 - Houston, Texas, United States
- Private Practice - Dr. Laila A. Hassan /ID# 272297 - Houston, Texas, United States
- University Of Texas Health Science Center /ID# 283308 - Houston, Texas, United States
- Care & Cure Clinic /ID# 281684 - Houston, Texas, United States
- Biopharma Informatic /ID# 279189 - Katy, Texas, United States
- Southwest Rheumatology Research /ID# 272268 - Mesquite, Texas, United States
- Texas Rheumatology Research Institute Llc /Id# 278010 - Plano, Texas, United States
- Epic Medical Research /ID# 272656 - Red Oak, Texas, United States
- Texas Digestive Disease Consultants - Southlake /ID# 277652 - Southlake, Texas, United States
- Fort Bend Rheumatology Associates /ID# 280761 - Sugar Land, Texas, United States
- DM Clinical Research - Tomball /ID# 272452 - Tomball, Texas, United States
- DM Clinical Research -Tomball RCH /ID# 281787 - Tomball, Texas, United States
- Annapolis Rheumatology /ID# 279144 - Fairfax, Virginia, United States
- Hoskinson Health & Wellness Clinic /ID# 281689 - Gillette, Wyoming, United States
- Clinical Research Investigator Group /ID# 274821 - Bayamón, Puerto Rico
- Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273212 - Budapest, Hungary
- Revita Reumatologiai Rendelo (Revita Kft.) /ID# 281247 - Budapest, Hungary
- Qualiclinic /ID# 281259 - Budapest, Hungary
Showing 60 of 104 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →