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 5308480, Arizona 5551752 85381

Private Practice - Dr. David S. Hallegua /ID# 277608
Beverly Hills 5328041, California 5332921 90211

Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826
Chula Vista 5336899, California 5332921 91910
Contact:
Site Coordinator
619-334-4735

Newport Huntington Medical Group /ID# 272439
Huntington Beach 5358705, California 5332921 92648-5994

Inland Rheumatology & Osteoporosis Medical Group /ID# 272449
Upland 5404915, California 5332921 91786

Tekton Research - Fort Collins - East Harmony Road /ID# 272472
Fort Collins 5577147, Colorado 5417618 80528

Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298
Avon Park 4146440, Florida 4155751 33825

Clinical Research Of West Florida - Phase I Unit /ID# 272428
Clearwater 4151316, Florida 4155751 33765

Neoclinical Research - Hialeah /ID# 272070
Hialeah 4158476, Florida 4155751 33016

Life Clinical Trials /ID# 272589
Margate 4163407, Florida 4155751 33063

HMD Research LLC /ID# 272432
Orlando 4167147, Florida 4155751 32819

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755
Tampa 4174757, Florida 4155751 33606
Contact:
Site Coordinator
813-870-1292

Deerbrook Medical Associates /ID# 273439
Libertyville 4899739, Illinois 4896861 60048

Willow Rheumatology and Wellness, PLLC /ID# 272691
Willowbrook 4916709, Illinois 4896861 60527

Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650
Lake Charles 4330236, Louisiana 4331987 70605

AA Medical Research Center - Grand Blanc /ID# 272496
Grand Blanc 4994320, Michigan 5001836 48439

Albuquerque Center For Rheumatology /ID# 272301
Albuquerque 5454711, New Mexico 5481136 87102

Joint And Muscle Research Institute /ID# 277290
Charlotte 4460243, North Carolina 4482348 28204

DJL Clinical Research, PLLC /ID# 272387
Charlotte 4460243, North Carolina 4482348 28211-1064

Paramount Medical Research and Consulting /ID# 272474
Middleburg Heights 5162851, Ohio 5165418 44130

Altoona Center For Clinical Research /ID# 272479
Duncansville 5187508, Pennsylvania 6254927 16635
Contact:
Site Coordinator
814-693-0300

Low Country Rheumatology /ID# 277607
Summerville 4597919, South Carolina 4597040 29486

West Tennessee Research Institute /ID# 272453
Jackson 4632595, Tennessee 4662168 38305

Arthritis & Rheumatology Research Institute /ID# 272299
Allen 4670300, Texas 4736286 75013

Tekton Research - West Gate /ID# 272270
Austin 4671654, Texas 4736286 78745

Arthritis Care Of Texas /ID# 277961
Corpus Christi 4683416, Texas 4736286 78415
Contact:
Site Coordinator
713-487-8680

Accurate Clinical Research - Houston /ID# 272271
Houston 4699066, Texas 4736286 77089-6142

Private Practice - Dr. Laila A. Hassan /ID# 272297
Houston 4699066, Texas 4736286 77089

Texas Rheumatology Research Institute Llc /Id# 278010
Plano 4719457, Texas 4736286 75024

Epic Medical Research /ID# 272656
Red Oak 4721921, Texas 4736286 75154

Dynamed Clinical Research - Tomball /ID# 272452
Tomball 4737094, Texas 4736286 77375

Clinical Research Investigator Group, LLC /ID# 274821
Bayamón 4562831, Puerto Rico 00960

Reuviva Research Center, LLC /ID# 277140
Guaynabo 4565119, Puerto Rico 00968-8050

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

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