A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

Purpose

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.

Condition

  • Rheumatoid Arthritis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Substudy 1: Lutikizumab Monotherapy 		Participants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B
  • Drug: Lutikizumab
    Subcutaneous (SC) injection
Placebo Comparator
Substudy 1: Matching Placebo Monotherapy 		Participants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy.
  • Drug: Placebo
    Subcutaneous (SC) injection
Experimental
Substudy 2: Ravagalimab Monotherapy 		Participants will be randomized to receive Ravagalimab
  • Drug: Ravagalimab
    Subcutaneous (SC) injection
Placebo Comparator
Substudy 2: Matching Placebo Monotherapy 		Participants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy
  • Drug: Placebo
    Subcutaneous (SC) injection
Experimental
SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy 		Participants will be randomized to be administered Lutikizumab and Ravagalimab doses
  • Drug: Lutikizumab
    Subcutaneous (SC) injection
  • Drug: Ravagalimab
    Subcutaneous (SC) injection
Placebo Comparator
Substudy 3: Matching Placebo Combination Therapy 		Participants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy
  • Drug: Placebo
    Subcutaneous (SC) injection

Recruiting Locations

Sun Valley Arthritis Center /ID# 278331
Peoria, Arizona 85381

Private Practice - Dr. David S. Hallegua /ID# 277608
Beverly Hills, California 90211

Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826
Chula Vista, California 91910
Contact:
Site Coordinator
619-334-4735

Newport Huntington Medical Group /ID# 272439
Huntington Beach, California 92648-5994

Cohen Medical Centers /ID# 278341
Thousand Oaks, California 91360

The Lundquist Institute /ID# 272481
Torrance, California 90502

Inland Rheumatology & Osteoporosis Medical Group /ID# 272449
Upland, California 91786

Tekton Research - Fort Collins - East Harmony Road /ID# 272472
Fort Collins, Colorado 80528

Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298
Avon Park, Florida 33825

Clinical Research Of West Florida - Phase I Unit /ID# 272428
Clearwater, Florida 33765

Neoclinical Research - Hialeah /ID# 272070
Hialeah, Florida 33016

South Florida Rheumatology /ID# 278339
Hollywood, Florida 33026

Swati Shah, MD Rheumatology /ID# 273624
Jacksonville, Florida 32257

Life Clinical Trials /ID# 272589
Margate, Florida 33063

HMD Research LLC /ID# 272432
Orlando, Florida 32819

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755
Tampa, Florida 33606
Contact:
Site Coordinator
813-870-1292

Deerbrook Medical Associates /ID# 273439
Libertyville, Illinois 60048

Willow Rheumatology and Wellness, PLLC /ID# 272691
Willowbrook, Illinois 60527

Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650
Lake Charles, Louisiana 70605

AA Medical Research Center - Grand Blanc /ID# 272496
Grand Blanc, Michigan 48439

Albuquerque Center For Rheumatology /ID# 272301
Albuquerque, New Mexico 87102

Joint And Muscle Research Institute /ID# 277290
Charlotte, North Carolina 28204

DJL Clinical Research, PLLC /ID# 272387
Charlotte, North Carolina 28211-1064

Paramount Medical Research and Consulting /ID# 272474
Middleburg Heights, Ohio 44130

Altoona Center For Clinical Research /ID# 272479
Duncansville, Pennsylvania 16635
Contact:
Site Coordinator
814-693-0300

Low Country Rheumatology /ID# 277607
Summerville, South Carolina 29486

West Tennessee Research Institute /ID# 272453
Jackson, Tennessee 38305

Arthritis & Rheumatology Research Institute /ID# 272299
Allen, Texas 75013

Tekton Research - West Gate /ID# 272270
Austin, Texas 78745

Trinity Universal Research Associates - Carrollton /ID# 272577
Carrollton, Texas 75007

Arthritis Care Of Texas /ID# 277961
Corpus Christi, Texas 78415
Contact:
Site Coordinator
713-487-8680

Accurate Clinical Research - Houston /ID# 272271
Houston, Texas 77089-6142

Private Practice - Dr. Laila A. Hassan /ID# 272297
Houston, Texas 77089

Southwest Rheumatology Research /ID# 272268
Mesquite, Texas 75150
Contact:
Site Coordinator
972-288-2600

Texas Rheumatology Research Institute Llc /Id# 278010
Plano, Texas 75024

Epic Medical Research /ID# 272656
Red Oak, Texas 75154

Dynamed Clinical Research - Tomball /ID# 272452
Tomball, Texas 77375

Clinical Research Investigator Group, LLC /ID# 274821
Bayamón, Puerto Rico 00960

Centro Reumatologico De Caguas /ID# 277918
Caguas, Puerto Rico 00725

Reuviva Research Center, LLC /ID# 277140
Guaynabo, Puerto Rico 00968-8050

Santurce Clinical Trials and Infusion Center /ID# 277927
San Juan, Puerto Rico 00909
Contact:
Site Coordinator
787-722-0662

GCM Medical Group, PSC /ID# 273016
San Juan, Puerto Rico 00917

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com