AzTrials
AzTrials

Rheumatoid ArthritisPhase 3AVERT-2NCT02504268

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

A Phase 3 study testing Abatacept and Methotrexate in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 201 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis. 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?
Abatacept and Methotrexate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
994 participants
Where
201 sitesin 31 countries
Study dates
3 Sep 2015to 19 Mar 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Rheumatoid arthritis (RA) diagnosis less than 6 months
  • CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h
  • At least 3 swollen and 3 tender joints
  • Anti-citrullinated protein antibodies (ACPA) positive

Who cannot join

  • At risk for tuberculosis
  • Have acute infection
  • Have chronic or recurrent bacterial or serious latent viral infection
  • History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
  • Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)

Trial locations and contacts

201 sites in 31 countries.

201 sites in 31 countries

United States42 sites

  • Albuquerque Center For Rheumatology

    Albuquerque, New Mexico, 87102

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Arthritis Clinic Of Northern Virginia, P.C.

    Arlington, Virginia, 22205

  • Joao Nascimento

    Bridgeport, Connecticut, 06606

  • Coeur D'Alene Arthrit Clin

    Coeur d'Alene, Idaho, 83814

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Spectrum Medical, Inc.

    Danville, Virginia, 24541

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • St. Paul Rheumatology, P.A.

    Eagan, Minnesota, 55121

  • Arthritis And Osteoporosis Associates, Pa

    Freehold, New Jersey, 07728

  • St. Joseph Heritage Medical Group

    Fullerton, California, 92835

  • Arizona Arthritis & Rheumatology Research PLLC

    Glendale, Arizona, 85306

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Klein And Associates, M.D., Pa

    Hagerstown, Maryland, 21740

  • Local Institution

    Hickory, North Carolina, 28601

  • CHI St. Vincent Medical Group Hot Springs

    Hot Springs, Arkansas, 71913

  • Houston Institute For Clinical Research

    Houston, Texas, 77074

  • Healthcare Partners Medical Group

    Huntington Beach, California, 92646

  • Rheumatology Associates Of North Alabama, P.C.

    Huntsville, Alabama, 35801

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Physician Research Collaboration, Llc

    Lincoln, Nebraska, 68516

  • Arkansas Primary Care Clinic

    Little Rock, Arkansas, 72204

  • Valerius Medical Group and Research Center

    Los Alamitos, California, 90720

  • Arizona Arthritis & Rheumatology Research PLLC

    Mesa, Arizona, 85210

  • Arthritis And Diabetes Clinic

    Monroe, Louisiana, 71203

  • Hospital For Special Surgery

    New York, New York, 10021-4892

  • Health Research Of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Rheumatology Associates Of Central Florida, P.A.

    Orlando, Florida, 32806

  • The Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Arizona Arthritis & Rheumatology Research PLLC

    Phoenix, Arizona, 85032

  • Arizona Arthritis & Rheumatology Research PLLC

    Phoenix, Arizona, 85037

  • Pmg Research Of Salisbury

    Salisbury, North Carolina, 28144

  • Arthritis Northwest

    Spokane, Washington, 99204

  • Arthritis Consultants

    St Louis, Missouri, 63141

  • Arizona Arthritis & Rheumatology Research PLLC

    Sun City, Arizona, 85351

  • Tampa Medical Group, Pa

    Tampa, Florida, 33614

  • Physicians Research Center, Llc

    Toms River, New Jersey, 08755

  • Oklahoma Ctr For Arthritis Therapy And Research, Inc.

    Tulsa, Oklahoma, 74104

  • Inland Rheumatology Clinical Trials Inc.

    Upland, California, 91786

  • Carolina Arthritis Associates

    Wilmington, North Carolina, 28401

  • Pmg Research Of Wilmington Llc

    Wilmington, North Carolina, 28401

  • Clinical Research Center Of Reading, Llp

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan27 sites

  • Local Institution

    Chuo-ku, Tokyo, 1048560

  • Local Institution

    Fukuoka, Fukuoka, 8108563

  • Local Institution

    Hamamatsu, Shizuoka, 4308558

  • Local Institution

    Hiroshima, Hiroshima, 7348551

  • Local Institution

    Hitachi-Naka, Ibaraki, 3120057

  • Local Institution

    Iruma-gun, Saitama, 3500495

  • Local Institution

    Isahaya-shi, Nagasaki, 8548501

  • Local Institution

    Izumisano, Osaka, 5988577

  • Local Institution

    Kagoshima, Kagoshima-ken, 8900063

  • Local Institution

    Kato-shi, Hyōgo, 6731462

  • Local Institution

    Kawachi-Nagano, Osaka, 5868521

  • Local Institution

    Kawagoe-shi, Saitama, 3508550

  • Local Institution

    Kitakyushu-shi, Fukuoka, 8078556

  • Local Institution

    Meguro-ku, Tokyo, 1528902

  • Local Institution

    Meguro-ku, Tokyo, 1538515

  • Local Institution

    Mito, Ibaraki, 3100015

  • Local Institution

    Nagoya, Aichi-ken, 4578511

  • Local Institution

    Nagoya, Aichi-ken, 4668560

  • Local Institution

    Sagamihara-shi, Kanagawa, 2520392

  • Local Institution

    Sapporo, Hokkaido, 0608604

  • Local Institution

    Sapporo, Hokkaido, 0608648

  • Local Institution

    Sapporo, Hokkaido, 0630811

  • Local Institution

    Sasebo-shi, Nagasaki, 8571195

  • Local Institution

    Sayama-shi, Saitama, 3501305

  • Local Institution

    Shinjuku-Ku, Tokyo, 1608582

  • Local Institution

    tabashi City, Tokyo, 1738610

  • Local Institution

    Tomigusuku-shi, Okinawa, 9010224

Other trials in Japan

Germany12 sites

  • Rheumapraxis Dr. Kurthen

    Aachen, 52064

  • Charite Campus Mitte

    Berlin, 10117

  • Rheumatologische Schwerpunktpraxis Dr. Zinke

    Berlin, 13055

  • Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch

    Berlin, 13125

  • Schlosspark-Klinik

    Berlin, 14059

  • Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken

    Burghausen, 84489

  • Klinikum Der Albrecht-Ludwigs-Universitat

    Freiburg im Breisgau, 79106

  • MVZ Rheuma

    Hamburg, 20095

  • Hamburger Rheuma Forschungszentrum

    Hamburg, 22391

  • Gemeinschaftspraxis Drs. von Hinueber u Demary

    Hildesheim, 31134

  • Rheumatologie In Wuermtal

    Planegg, 82152

  • Praxis Dr. Walter

    Rendsburg, 24768

Other trials in Germany

Argentina11 sites

  • Instituto De Rehabilitacion Psicofisica

    Buenos Aires, 1428

  • Organizacion Medica De Investigacion S.A. (Omi)

    Capital Federal, Buenos Aires, 1015

  • Local Institution

    Ciudad Autonoma Beunos Aires, Buenos Aires, 1431

  • Hospital General De Agudos J.M. Ramos Mejia

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1221

  • Centro Consultora Integral de Salud SRL

    Córdoba, 5004

  • Hospital Privado-Centro Medico De Cordoba S.A.

    Córdoba, 5016

  • Framingham Centro Medico

    La Plata, Buenos Aires, 1902

  • Caici

    Rosario, Santa Fe Province, 2000

  • Instituto de Asistencia Reumatologica Integral

    San Fernando, Buenos Aires, 1646

  • Centro De Investigaciones Reumatologicas

    San Miguel de Tucumán, 4000

  • Centro Medico Privado De Reumatologia

    San Miguel de Tucumán, 4000

Other trials in Argentina

Mexico9 sites

  • Local Institution

    Guadalajara, Jalisco, 44280

  • Local Institution

    Guadalajara, Jalisco, 44600

  • Local Institution

    Guadalajara, Jalisco

  • Local Institution

    Guadalajara

  • Local Institution

    León, Guanajuato, 37000

  • Local Institution

    Mexicali, Estado de Baja California

  • Local Institution

    Mexico City, Distrito Fededral, 11850

  • Local Institution

    México D.F.

  • Local Institution

    San Luis Potosí City, 78213

Other trials in Mexico

Brazil8 sites

  • Local Institution

    Curitiba, Paraná, 80030-110

  • Local Institution

    Juiz de Fora, Minas Gerais, 36010-570

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Local Institution

    Santo André, São Paulo, 09060-870

  • Local Institution

    São Paulo, 01228-200

  • Local Institution

    São Paulo, 04032-060

  • Local Institution

    São Paulo, 04266-010

  • Local Institution

    Varginha, Minas Gerais, 37006-710

Other trials in Brazil

Poland7 sites

  • Nszoz Unica Cr

    Dąbrówka, 62-069

  • Nzoz Mak Med

    Nadarzyn, 05-830

  • SANUS Szpital Specjalistyczny Sp. z o.o.

    Stalowa Wola, 37-450

  • Local Institution

    Staszów, 28-200

  • Slaski Szpital Reumatologiczno - Rehabilitacyjny

    Ustroń, 43-450

  • Instytut Reumatologii, I Klinika Reumatologii

    Warsaw, 02637

  • Centrum Medyczne AMED Sp. z o.o.

    Warsaw, 03-291

Other trials in Poland

Hungary6 sites

  • Local Institution

    Budapest, 1027

  • Belgyogy. Int. Reuma. DEOEC

    Debrecen, 4032

  • Vaszary Kolos Hospital

    Esztergom, 2500

  • Reumatologiai Osztaly Flor F.

    Kistarcsa, 2143

  • Reumatologiai Osztaly MAV

    Szolnok, 5000

  • Vital Medical Center

    Veszprém, 8200

Other trials in Hungary

Italy6 sites

  • Ospedale Vittorio Emanuele

    Catania, 95123

  • Istituto Gaetano Pini

    Milan, 20122

  • Azienda Ospedaliera Luigi Sacco

    Milan, 20154

  • Local Institution

    Pavia, 27100

  • Local Institution

    Roma, 00168

  • Ospedale Borgo Roma

    Verona, 37134

Other trials in Italy

Australia5 sites

  • Local Institution

    Camberwell, Victoria, 3124

  • Local Institution

    Coffs Harbour, 2450

  • Local Institution

    Hobart, Tasmania, 7000

  • Local Institution

    Maroochydore, Queensland, 4558

  • Local Institution

    Southport, Queensland, 4215

Other trials in Australia

Israel5 sites

  • Local Institution

    Haifa, 31096

  • Local Institution

    Petah Tikva, 4941492

  • Local Institution

    Ramat Gan, 52621

  • Local Institution

    Tel HaShomer, 52620

  • Local Institution

    Zrifin

Other trials in Israel

Russia5 sites

  • Local Institution

    Moscow, 119049

  • Local Institution

    Saint Petersburg, 191124

  • Local Institution

    Saint Petersburg, 197022

  • Local Institution

    Yaroslavl, 150003

  • Local Institution

    Yekaterinburg, 620102

Other trials in Russia

South Africa5 sites

  • Local Institution

    Cape Town, Western Cape, 7500

  • Local Institution

    Pinelands, Cape Town, Western Cape, 7405

  • Local Institution

    Port Elizabeth, Eastern Cape, 6045

  • Local Institution

    Soweto, Gauteng, 2013

  • Local Institution

    Stellenbosch, Western Cape, 7600

Other trials in South Africa

Spain5 sites

  • Local Institution

    A Coruña, 15006

  • Local Institution

    Barcelona, 08036

  • Local Institution

    Madrid, 28006

  • Local Institution

    Madrid, 28046

  • Local Institution

    Santiago Compostela, 15702

Other trials in Spain

Canada4 sites

  • Local Institution

    Montreal, Quebec, H2L 1S6

  • Local Institution

    Saskatchewan, Saskatchewan, S7K 0H6

  • Centre De Recherche Musculo-Squelettique

    Trois-Rivières, Quebec, G8Z 1Y2

  • Local Institution

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Colombia4 sites

  • Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S

    Bogotá

  • Fundacion Instituto de Reumatologia Fernando Chalem

    Bogotá

  • Clinica de Artritis Temprana

    Cali

  • Hospital Pablo Tobon Uribe

    Medellín, MEDELLIN

Other trials in Colombia

Czechia4 sites

  • Oddeleni klinicke farmakologie

    Plzen-Bory, 305 99

  • Revmatologicky ustav

    Prague, 128 50

  • MEDICAL PLUS, s.r.o.

    Uherské Hradiště, 686 01

  • PV Medical Services, s.r.o.

    Zlín, 760 01

Other trials in Czechia

France4 sites

  • Local Institution

    Lyon, 69437

  • Local Institution

    Orléans, 45067

  • Local Institution

    Poitiers, 86021

  • Local Institution

    Toulouse, 31059

Other trials in France

Peru4 sites

  • Local Institution

    Lima, 27

  • Acq Medic Sac

    Lima, LIMA 11

  • Clinica El Golf

    Lima, Lima 27

  • Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

    Lima, LIMA 33

Other trials in Peru

Sweden4 sites

  • Local Institution

    Gothenburg, 413 45

  • Local Institution

    Malmö, 205 02

  • Local Institution

    Stockholm, 171 76

  • Local Institution

    Uppsala, 751 85

Other trials in Sweden

Taiwan4 sites

  • Local Institution

    Tainan, 704

  • Local Institution

    Taipei, 100

  • Local Institution

    Taipei, 112

  • Local Institution

    Taoyuan, 333

Other trials in Taiwan

Chile3 sites

  • Centro De Estudios Reumatologicos

    Santiago, Santiago Metropolitan, 7501126

  • Someal

    Santiago, Santiago Metropolitan, 7510586

  • Centro Medico de Reumatologia Limitada

    Temuco, Araucania, 4790928

Other trials in Chile

Romania3 sites

  • Local Institution

    Bucharest, 011192

  • Local Institution

    Bucharest, 020983

  • Local Institution

    Cluj-Napoca, 400006

Other trials in Romania

South Korea3 sites

  • Local Institution

    Anyang-si, Gyeonggi-do, 14068

  • Local Institution

    Seongnam-si, Gyeonggi-do, 13620

  • Local Institution

    Seoul, 04763

Other trials in South Korea

United Kingdom3 sites

  • Local Institution

    Hull, HU3 2JZ

  • Local Institution

    Leeds, North Yorkshire, LS7 4SA

  • Local Institution

    Manchester, M13 9WL

Other trials in United Kingdom

Finland2 sites

  • Local Institution

    Hyvinkää, 05800

  • Local Institution

    Kuopio, 70110

Other trials in Finland

Singapore2 sites

  • Local Institution

    Singapore, 117549

  • Local Institution

    Singapore, 169856

Other trials in Singapore

Austria1 site

  • Rheuma Zentrum Favoriten

    Vienna, 1100

Other trials in Austria

Monaco1 site

  • Local Institution

    Monaco, 98012

Other trials in Monaco

Netherlands1 site

  • Local Institution

    Leiden, 2333 ZA

Other trials in Netherlands

Qatar1 site

  • Local Institution

    Doha

Other trials in Qatar

About this study

Official title: A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive

The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

Read the detailed description

Subcutaneous (SC)

Being tested
Abatacept, Methotrexate, Abatacept Placebo, Methotrexate Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • AbataceptDrug

  • MethotrexateDrug

  • Abatacept PlaceboOther

  • Methotrexate PlaceboOther

Study groups in NCT02504268
Study groupRoleWhat they receive
Combination Therapy: Abatacept + MethotrexateExperimentalAbatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
Receives: Drug: Abatacept; Drug: Methotrexate
Methotrexate treatmentActive comparatorMethotrexate at least 15mg per week tablet or capsule orally
Receives: Drug: Methotrexate
Abatacept PlaceboPlacebo comparatorPlacebo for Abatacept subcutaneous injection once per week
Receives: Other: Abatacept Placebo
Methotrexate PlaceboPlacebo comparatorPlacebo to match Methotrexate capsule orally once per week
Receives: Other: Methotrexate Placebo

What is being measured

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

  1. Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24

    Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3.

    Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.

    Measured: Week 24

Secondary outcomes (4)

  1. Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24

    DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP <= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.

    Measured: Week 24

  2. Percentage of Participants in SDAI Remission at Week 52

    Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.

    Measured: Week 52

  3. Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52

    The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.

    Measured: Week 52

  4. Percentage of Participants in Boolean Remission at Week 52

    Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.

    Measured: Week 52

Timeline

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

  1. First posted21 Jul 2015 (estimated)
  2. Study start3 Sep 2015
  3. Primary completion16 Jan 2017
  4. Study completion19 Mar 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
994 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02504268
Sponsor's protocol ID
IM101-550
Other IDs
2015-001275-50, 2015
Acronym
AVERT-2
Status last verified
Jun 2021
First submitted
20 Jul 2015
Last updated
28 Jun 2021
Data monitoring committee
No

Publications

  • Emery P, Fleischmann R, Wong R, Lozenski K, Tanaka Y, Bykerk V, Bingham CO 3rd, Huizinga TWJ, Citera G, Perera V, Murthy B, Maxwell KF, Passarell J, Hedrich WD, Williams D. Association Between Abatacept Exposure Levels and Infection Occurrence in Patients With Rheumatoid Arthritis: Post Hoc Analysis of the AVERT-2 Study. J Rheumatol. 2025 May 1;52(5):426-435. doi: 10.3899/jrheum.2024-0498.

    PubMed 39814436

  • Emery P, Tanaka Y, Bykerk VP, Bingham CO, Huizinga TWJ, Citera G, Huang KG, Wu C, Connolly SE, Elbez Y, Wong R, Lozenski K, Fleischmann R. The trajectory of clinical responses in patients with early rheumatoid arthritis who achieve sustained remission in response to abatacept: subanalysis of AVERT-2, a randomized phase IIIb study. Arthritis Res Ther. 2023 Apr 22;25(1):67. doi: 10.1186/s13075-023-03038-2.

    PubMed 37087459

  • Emery P, Tanaka Y, Bykerk VP, Huizinga TWJ, Citera G, Bingham CO 3rd, Banerjee S, Soule BP, Nys M, Connolly SE, Lozenski KL, Zhuo J, Wong R, Huang KG, Fleischmann R. Sustained Remission and Outcomes with Abatacept plus Methotrexate Following Stepwise Dose De-escalation in Patients with Early Rheumatoid Arthritis. Rheumatol Ther. 2023 Jun;10(3):707-727. doi: 10.1007/s40744-022-00519-9. Epub 2023 Mar 3.

    PubMed 36869251

  • Wu C, Hu Y, Schafer P, Connolly SE, Wong R, Nielsen SH, Bay-Jensen AC, Emery P, Tanaka Y, Bykerk VP, Bingham CO, Huizinga TW, Fleischmann R, Liu J. Baseline serum levels of cross-linked carboxy-terminal telopeptide of type I collagen predict abatacept treatment response in methotrexate-naive, anticitrullinated protein antibody-positive patients with early rheumatoid arthritis. RMD Open. 2022 Dec;8(2):e002683. doi: 10.1136/rmdopen-2022-002683.

    PubMed 36585217

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abatacept and Methotrexate in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 201 sites in 31 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in United States, Japan, Germany, Argentina, Mexico and 26 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02504268, which also lists 4 linked publications.

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 28 Jun 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in