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Rheumatoid ArthritisPhase 2NCT06972446

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

A Phase 2 study testing Lutikizumab and Ravagalimab in people with Rheumatoid Arthritis, run by AbbVie at 96 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Lutikizumab and Ravagalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
96 sitesin 12 countries
Study dates
20 Jun 2025to Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

96 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

96 sites in 12 countries

United States49 sites, 49 recruiting
  • Albuquerque Center For Rheumatology /ID# 272301

    Albuquerque, New Mexico, 87102

    Recruiting
  • Tekton Research - West Gate /ID# 272270

    Austin, Texas, 78745

    Recruiting
  • Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298

    Avon Park, Florida, 33825

    Recruiting
  • Private Practice - Dr. David S. Hallegua /ID# 277608

    Beverly Hills, California, 90211

    Recruiting
  • Trinity Universal Research Associates - Carrollton /ID# 272577

    Carrollton, Texas, 75007

    Recruiting
  • Joint And Muscle Research Institute /ID# 277290

    Charlotte, North Carolina, 28204

    Recruiting
  • DJL Clinical Research - Charlotte /ID# 272387

    Charlotte, North Carolina, 28211-1064

    Recruiting
  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422

    Chicago, Illinois, 60611

    Recruiting
  • Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826

    Chula Vista, California, 91910

    Site Coordinator, 619-334-4735

    Recruiting
  • Clinical Research Of West Florida - Phase I Unit /ID# 272428

    Clearwater, Florida, 33765

    Recruiting
  • Arthritis Care Of Texas /ID# 277961

    Corpus Christi, Texas, 78415

    Site Coordinator, 713-487-8680

    Recruiting
  • Altoona Center For Clinical Research /ID# 272479

    Duncansville, Pennsylvania, 16635

    Site Coordinator, 814-693-0300

    Recruiting
  • Tekton Research - Fort Collins - East Harmony Road /ID# 272472

    Fort Collins, Colorado, 80528

    Recruiting
  • Arthritis and Rheumatology Research Institute - Frisco /ID# 272299

    Frisco, Texas, 75035

    Recruiting
  • AA Medical Research Center - Grand Blanc /ID# 272496

    Grand Blanc, Michigan, 48439

    Recruiting
  • Northwell Health Physician Partners Rheumatology At Great Neck /ID# 275621

    Great Neck, New York, 11021

    Recruiting
  • Finlay Medical Research - Greenacres /ID# 281654

    Greenacres City, Florida, 33467

    Recruiting
  • Neoclinical Research - Hialeah /ID# 272070

    Hialeah, Florida, 33016

    Recruiting
  • South Florida Rheumatology /ID# 278339

    Hollywood, Florida, 33026

    Recruiting
  • Accurate Clinical Research - Houston /ID# 272271

    Houston, Texas, 77089-6142

    Recruiting
  • Private Practice - Dr. Laila A. Hassan /ID# 272297

    Houston, Texas, 77089

    Recruiting
  • Care & Cure Clinic /ID# 281684

    Houston, Texas, 77909

    Site Coordinator, 832-234-1023

    Recruiting
  • Newport Huntington Medical Group /ID# 272439

    Huntington Beach, California, 92648-5994

    Recruiting
  • West Tennessee Research Institute /ID# 272453

    Jackson, Tennessee, 38305

    Recruiting
  • Swati Shah, MD Rheumatology /ID# 273624

    Jacksonville, Florida, 32257

    Recruiting
  • Arthritis And Rheumatism Associates (Ara) - Jonesboro /ID# 272896

    Jonesboro, Arkansas, 72401

    Recruiting
  • Biopharma Informatic /ID# 279189

    Katy, Texas, 77494

    Recruiting
  • Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650

    Lake Charles, Louisiana, 70605

    Recruiting
  • Deerbrook Medical Associates /ID# 273439

    Libertyville, Illinois, 60048

    Recruiting
  • Life Clinical Trials - Colonial Drive - Margate /ID# 272589

    Margate, Florida, 33063

    Recruiting
  • Southwest Rheumatology Research /ID# 272268

    Mesquite, Texas, 75150

    Site Coordinator, 972-288-2600

    Recruiting
  • Paramount Medical Research and Consulting /ID# 272474

    Middleburg Heights, Ohio, 44130

    Recruiting
  • Advanced Quality Medical Research /ID# 277824

    Orland Park, Illinois, 60462

    Recruiting
  • HMD Research LLC /ID# 272432

    Orlando, Florida, 32819

    Recruiting
  • Vitalia Research /ID# 272478

    Palm Beach Gardens, Florida, 33410

    Recruiting
  • Sun Valley Arthritis Center /ID# 278331

    Peoria, Arizona, 85381

    Recruiting
  • Texas Rheumatology Research Institute /ID# 278010

    Plano, Texas, 75024

    Recruiting
  • Epic Medical Research /ID# 272656

    Red Oak, Texas, 75154

    Recruiting
  • Arnold Arthritis & Rheumatology /ID# 278354

    Skokie, Illinois, 60076

    Recruiting
  • Fort Bend Rheumatology Associates /ID# 280761

    Sugar Land, Texas, 77479

    Recruiting
  • Low Country Rheumatology /ID# 277607

    Summerville, South Carolina, 29486

    Recruiting
  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755

    Tampa, Florida, 33606

    Site Coordinator, 813-870-1292

    Recruiting
  • Cohen Medical Centers /ID# 278341

    Thousand Oaks, California, 91360

    Recruiting
  • DM Clinical Research - Tomball /ID# 272452

    Tomball, Texas, 77375

    Recruiting
  • Dm Clinical Research -Tomball Rch /ID# 281787

    Tomball, Texas, 77377

    Recruiting
  • The Lundquist Institute /ID# 272481

    Torrance, California, 90502

    Recruiting
  • Inland Rheumatology and Osteoporosis Medical Group /ID# 272449

    Upland, California, 91786

    Recruiting
  • Sahni Rheumatology & Therapy /ID# 278352

    West Long Branch, New Jersey, 07764

    Recruiting
  • Willow Rheumatology and Wellness /ID# 272691

    Willowbrook, Illinois, 60527

    Recruiting

Other trials in United States

Poland7 sites, 7 recruiting
  • Medicover Integrated Clinical Services - Bydgoszcz (SMO/Network/Consortium) /ID# 272975

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-068

    Recruiting
  • Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy /ID# 281180

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

    Recruiting
  • Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 272966

    Elblag, Warmian-Masurian Voivodeship, 82-300

    Recruiting
  • Malopolskie Centrum Kliniczne /ID# 272965

    Krakow, Lesser Poland Voivodeship, 30-149

    Recruiting
  • Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 281209

    Krakow, Lesser Poland Voivodeship, 31-011

    Recruiting
  • Etyka Osrodek Badan Klinicznych /ID# 272974

    Olsztyn, Warmian-Masurian Voivodeship, 10-117

    Recruiting
  • Centrum Medyczne Reuma Park /ID# 272968

    Warsaw, Masovian Voivodeship, 02-665

    Recruiting

Other trials in Poland

Puerto Rico7 sites, 7 recruiting
  • Clinical Research Investigator Group /ID# 274821

    Bayamón, 00960

    Recruiting
  • Centro Reumatologico De Caguas /ID# 277918

    Caguas, 00725

    Recruiting
  • Reuviva Research Center /ID# 277140

    Guaynabo, 00968-8050

    Recruiting
  • Clinical Research Puerto Rico. /ID# 281346

    San Juan, 00909-1738

    Recruiting
  • Santurce Clinical Trials and Infusion Center /ID# 277927

    San Juan, 00909

    Site Coordinator, 787-722-0662

    Recruiting
  • GCM Medical Group, PSC /ID# 273016

    San Juan, 00917

    Recruiting
  • Mindful Medical Research /ID# 281521

    San Juan, 00918-3756

    Site Coordinator, 787-765-9034

    Recruiting

Other trials in Puerto Rico

Spain7 sites, 7 recruiting
  • Complejo Hospitalario Universitario A Coruna /ID# 272609

    A Coruña, 15006

    Recruiting
  • Hospital de Basurto /ID# 272610

    Bilbao, Vizcaya, 48013

    Recruiting
  • Hospital Universitario Reina Sofia /ID# 272613

    Córdoba, 14004

    Recruiting
  • Hospital General Universitario Gregorio Maranon /ID# 272616

    Madrid, 28007

    Recruiting
  • Hospital Universitari Parc Tauli /ID# 272607

    Sabadell, Barcelona, 08208

    Recruiting
  • Hospital Universitario de Valme /ID# 281266

    Seville, Sevilla, 41014

    Recruiting
  • Consorci Hospital General Universitario de Valencia /ID# 272615

    Valencia, 46014

    Recruiting

Other trials in Spain

Hungary6 sites, 6 recruiting
  • Semmelweis Egyetem Reumatologiai es Immunologiai Klinika /ID# 273212

    Budapest, 1023

    Recruiting
  • Revita Reumatologiai Rendelo (Revita Kft.) /ID# 281247

    Budapest, 1027

    Recruiting
  • Qualiclinic /ID# 281259

    Budapest, 1134

    Recruiting
  • Szegedi Tudomanyegyetem /ID# 272865

    Szeged, Csongrád megye, 6720

    Recruiting
  • Complex Rendelo Med Zrt. /ID# 272859

    Székesfehérvár, Fejér, 8000

    Recruiting
  • Vital-Medicina /ID# 272858

    Veszprém, Fejér, 8200

    Recruiting

Other trials in Hungary

Germany4 sites, 4 recruiting
  • Universitaetsklinikum Bonn /ID# 272808

    Bonn, North Rhine-Westphalia, 53127

    Recruiting
  • Krankenhaus Porz Am Rhein /ID# 272903

    Cologne, North Rhine-Westphalia, 51149

    Recruiting
  • Mvz Rheuma /ID# 272795

    Hamburg, 20095

    Recruiting
  • Rheumateam Lahn-Dill-Siegerland /ID# 274858

    Wetzlar, Hesse, 35578

    Recruiting

Other trials in Germany

Serbia4 sites, 4 recruiting
  • Institute Of Rheumatology /ID# 280054

    Belgrade, Beograd, 11000

    Recruiting
  • Institute Of Rheumatology /ID# 280055

    Belgrade, Beograd, 11000

    Recruiting
  • Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280057

    Novi Sad, Juznobacki Okrug, 21000

    Recruiting
  • Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280058

    Novi Sad, Juznobacki Okrug, 21000

    Recruiting

Other trials in Serbia

South Korea4 sites, 4 recruiting
  • SoonChunHyang University Hospital Cheonan /ID# 277624

    Cheonan-si, Chungcheongnam-do, 31151

    Recruiting
  • Hanyang University Seoul Hospital /ID# 273625

    Seoul, Seoul Teugbyeolsi, 04763

    Recruiting
  • SMG-SNU Boramae Medical Center /ID# 273627

    Seoul, Seoul Teugbyeolsi, 07061

    Recruiting
  • Ajou University Hospital - Suwon-si /ID# 273647

    Suwon, Gyeonggido, 16499

    Recruiting

Other trials in South Korea

Canada3 sites, 3 recruiting
  • Care Clinic - Calgary /ID# 274405

    Calgary, Alberta, T2N 4L7

    Recruiting
  • Dr. Latha Naik Medical Professional Corporation /ID# 274403

    Saskatoon, Saskatchewan, S7H 0P4

    Recruiting
  • Centre Hospitalier Universite De Sherbrooke - Hotel-Dieu Hospital /ID# 273711

    Sherbrooke, Quebec, J1G 2E8

    Recruiting

Other trials in Canada

Czechia3 sites, 3 recruiting
  • L.K.N. Arthrocentrum /ID# 271932

    Hlučín, Moravian-Silesian Region, 748 01

    Recruiting
  • MEDICAL PLUS Research s.r.o /ID# 271926

    Uherské Hradiště, 686 01

    Recruiting
  • PV Medical Services /ID# 271934

    Zlín, 760 01

    Recruiting

Other trials in Czechia

Slovakia1 site, 1 recruiting
  • MEDMAN s.r.o. /ID# 278688

    Martin, Žilina Region, 036 01

    Recruiting

Other trials in Slovakia

Taiwan1 site, 1 recruiting
  • Taoyuan General Hospital /ID# 280044

    Taoyuan City, 330

    Recruiting

Other trials in Taiwan

About this study

Official title: A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis

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.

Being tested
Lutikizumab, Placebo, Ravagalimab
Keywords
Rheumatoid Arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LutikizumabDrug

    Subcutaneous (SC) injection

  • PlaceboDrug

    Subcutaneous (SC) injection

  • RavagalimabDrug

    Subcutaneous (SC) injection

Study groups in NCT06972446
Study groupRoleWhat they receive
Substudy 1: Lutikizumab MonotherapyExperimentalParticipants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B
Receives: Drug: Lutikizumab
Substudy 1: Matching Placebo MonotherapyPlacebo comparatorParticipants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy.
Receives: Drug: Placebo
Substudy 2: Ravagalimab MonotherapyExperimentalParticipants will be randomized to receive Ravagalimab
Receives: Drug: Ravagalimab
Substudy 2: Matching Placebo MonotherapyPlacebo comparatorParticipants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy
Receives: Drug: Placebo
SubStudy 3: Lutikizumab and Ravagalimab Combination TherapyExperimentalParticipants will be randomized to be administered Lutikizumab and Ravagalimab doses
Receives: Drug: Lutikizumab; Drug: Ravagalimab
Substudy 3: Matching Placebo Combination TherapyPlacebo comparatorParticipants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:

    1. ≥ 50% improvement in 68-tender joint count;
    2. ≥ 50% improvement in 66-swollen joint count; and
    3. ≥ 50% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP)

    Measured: At Week 12

  2. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately Week 22

Secondary outcomes (7)
  1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

    1. ≥ 20% improvement in 68-tender joint count;
    2. ≥ 20% improvement in 66-swollen joint count; and
    3. ≥ 20% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP)

    Measured: At Week 12

  2. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:

    1. ≥ 70% improvement in 68-tender joint count;
    2. ≥ 70% improvement in 66-swollen joint count; and
    3. ≥ 70% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP)

    Measured: At Week 12

  3. Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)

    The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity). LDA is defined as a score of < or = to 3.2.

    Measured: At Week 12

  4. Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP)

    The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity). CR remission is defined as a score of less than 2.6

    Measured: At Week 12

  5. Change from Baseline in DAS28 (CRP)

    The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity.

    Measured: At Week 12

  6. Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI)

    The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 21 with higher scores indicating higher disease activity. LDA is defined as a score from 2.8 to ≤ 10.

    Measured: At Week 12

  7. Percentage Of Participants Achieving CR per CDAI

    The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 21 with higher scores indicating higher disease activity. CR remission is defined as a score of less than 2.8

    Measured: At Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2025
  2. Study start20 Jun 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06972446
Sponsor's protocol ID
M25-056
Other IDs
2025-520721-21-00, 2025
Status last verified
Oct 2026
First submitted
7 May 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lutikizumab and Ravagalimab in people with Rheumatoid Arthritis, run by AbbVie at 96 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Poland, Puerto Rico, Spain, Hungary and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response (time frame: At Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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