Effects of Abatacept in Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— AVERT-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504268
• Other study ID #: IM101-550
• Secondary ID: 2015-001275-50
• Status: Completed
• Phase: Phase 3
• Start date: September 3, 2015
• Est. completion date: March 19, 2020

Study information

• Verified date: June 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Subcutaneous (SC)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 994
• Est. completion date: March 19, 2020
• Est. primary completion date: January 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept

• Methotrexate

Other:
• Abatacept Placebo

• Methotrexate Placebo

Locations

Country	Name	City	State
Argentina	Instituto De Rehabilitacion Psicofisica	Buenos Aires
Argentina	Organizacion Medica De Investigacion S.A. (Omi)	Capital Federal	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma Beunos Aires	Buenos Aires
Argentina	Hospital General De Agudos J.M. Ramos Mejia	Ciudad Autonoma De Buenos Aire	Buenos Aires
Argentina	Centro Consultora Integral de Salud SRL	Cordoba
Argentina	Hospital Privado-Centro Medico De Cordoba S.A.	Cordoba
Argentina	Framingham Centro Medico	La Plata	Buenos Aires
Argentina	Caici	Rosario	Santa FE
Argentina	Instituto de Asistencia Reumatologica Integral	San Fernando	Buenos Aires
Argentina	Centro De Investigaciones Reumatologicas	Tucuman
Argentina	Centro Medico Privado De Reumatologia	Tucuman
Australia	Local Institution	Camberwell	Victoria
Australia	Local Institution	Coffs Harbour
Australia	Local Institution	Hobart	Tasmania
Australia	Local Institution	Maroochydore	Queensland
Australia	Local Institution	Southport	Queensland
Austria	Rheuma Zentrum Favoriten	Wien
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Juiz De Fora	Minas Gerais
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Santo Andre	SAO Paulo
Brazil	Local Institution	Sao Paulo
Brazil	Local Institution	Sao Paulo
Brazil	Local Institution	Sao Paulo
Brazil	Local Institution	Varginha	Minas Gerais
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Saskatchewan
Canada	Centre De Recherche Musculo-Squelettique	Trois-rivieres	Quebec
Canada	Local Institution	Winnipeg	Manitoba
Chile	Someal	Santiago	Metropolitana
Chile	Centro De Estudios Reumatologicos	Santiago De Chile	Metropolitana
Chile	Centro Medico de Reumatologia Limitada	Temuco	Araucania
Colombia	Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S	Bogota
Colombia	Fundacion Instituto de Reumatologia Fernando Chalem	Bogota
Colombia	Clinica de Artritis Temprana	Cali
Colombia	Hospital Pablo Tobon Uribe	Medellin
Czechia	Oddeleni klinicke farmakologie	Plzen-Bory
Czechia	Revmatologicky ustav	Praha 2
Czechia	MEDICAL PLUS, s.r.o.	Uherske Hradiste
Czechia	PV Medical Services, s.r.o.	Zlin
Finland	Local Institution	Hyvinkaa
Finland	Local Institution	Kuopio
France	Local Institution	Lyon Cedex 03
France	Local Institution	Orleans cedex 2
France	Local Institution	Poitiers
France	Local Institution	Toulouse cedex 9
Germany	Rheumapraxis Dr. Kurthen	Aachen
Germany	Charite Campus Mitte	Berlin
Germany	Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch	Berlin
Germany	Rheumatologische Schwerpunktpraxis Dr. Zinke	Berlin
Germany	Schlosspark-Klinik	Berlin
Germany	Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken	Burghausen
Germany	Klinikum Der Albrecht-Ludwigs-Universitat	Freiburg
Germany	Hamburger Rheuma Forschungszentrum	Hamburg
Germany	MVZ Rheuma	Hamburg
Germany	Gemeinschaftspraxis Drs. von Hinueber u Demary	Hildesheim
Germany	Rheumatologie In Wuermtal	Planegg
Germany	Praxis Dr. Walter	Rendsburg
Hungary	Local Institution	Budapest
Hungary	Belgyogy. Int. Reuma. DEOEC	Debrecen
Hungary	Vaszary Kolos Hospital	Esztergom
Hungary	Reumatologiai Osztaly Flor F.	Kistarcsa
Hungary	Reumatologiai Osztaly MAV	Szolnok
Hungary	Vital Medical Center	Veszprem
Israel	Local Institution	Haifa
Israel	Local Institution	Petach Tikva
Israel	Local Institution	Ramat-gan
Israel	Local Institution	Tel Hashomer
Israel	Local Institution	Zrifin
Italy	Ospedale Vittorio Emanuele	Catania
Italy	Azienda Ospedaliera Luigi Sacco	Milano
Italy	Istituto Gaetano Pini	Milano
Italy	Local Institution	Pavia
Italy	Local Institution	Roma
Italy	Ospedale Borgo Roma	Verona
Japan	Local Institution	Chuo-ku	Tokyo
Japan	Local Institution	Fukuoka-shi	Fukuoka
Japan	Local Institution	Hamamatsu-shi	Shizuoka
Japan	Local Institution	Hiroshima-Shi	Hiroshima
Japan	Local Institution	Hitachinaka-shi	Ibaraki
Japan	Local Institution	Iruma-gun	Saitama
Japan	Local Institution	Isahaya-shi	Nagasaki
Japan	Local Institution	Itabashi-ku	Tokyo
Japan	Local Institution	Izumisano-shi	Osaka
Japan	Local Institution	Kagoshima-shi	Kagoshima
Japan	Local Institution	Kato-shi	Hyogo
Japan	Local Institution	Kawachinagano	Osaka
Japan	Local Institution	Kawagoe-shi	Saitama
Japan	Local Institution	Kitakyushu-shi	Fukuoka
Japan	Local Institution	Meguro-ku	Tokyo
Japan	Local Institution	Meguro-ku	Tokyo
Japan	Local Institution	Mito-shi	Ibaraki
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Sagamihara-shi	Kanagawa
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sasebo-shi	Nagasaki
Japan	Local Institution	Sayama-shi	Saitama
Japan	Local Institution	Shinjuku-Ku	Tokyo
Japan	Local Institution	Tomigusuku-shi	Okinawa
Korea, Republic of	Local Institution	Anyang-si	Gyeonggi-do
Korea, Republic of	Local Institution	Seongnam-si	Gyeonggi-do
Korea, Republic of	Local Institution	Seoul
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara
Mexico	Local Institution	León	Guanajuato
Mexico	Local Institution	Mexicali	Baja California
Mexico	Local Institution	Mexico City	Distrito Fededral
Mexico	Local Institution	México D.F.
Mexico	Local Institution	San Luis Potosi
Monaco	Local Institution	Monaco
Netherlands	Local Institution	Leiden
Peru	Acq Medic Sac	Lima
Peru	Clinica El Golf	Lima
Peru	Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac	Lima
Peru	Local Institution	Lima
Poland	Nszoz Unica Cr	Dabrowka
Poland	Nzoz Mak Med	Nadarzyn
Poland	SANUS Szpital Specjalistyczny Sp. z o.o.	Stalowa Wola
Poland	Local Institution	Staszow
Poland	Slaski Szpital Reumatologiczno - Rehabilitacyjny	Ustron
Poland	Centrum Medyczne AMED Sp. z o.o.	Warszawa
Poland	Instytut Reumatologii, I Klinika Reumatologii	Warszawa
Qatar	Local Institution	Doha
Romania	Local Institution	Bucharest
Romania	Local Institution	Bucuresti
Romania	Local Institution	Cluj-napoca
Russian Federation	Local Institution	Ekaterinburg
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	St Petersburg
Russian Federation	Local Institution	St.petersburg
Russian Federation	Local Institution	Yaroslavl
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
South Africa	Local Institution	Cape Town	Western CAPE
South Africa	Local Institution	Pinelands, Cape Town	Western Cape
South Africa	Local Institution	Port Elizabeth	Eastern CAPE
South Africa	Local Institution	Soweto	Gauteng
South Africa	Local Institution	Stellenbosch	Western Cape
Spain	Local Institution	A Coruna
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Santiago Compostela
Sweden	Local Institution	Goteborg
Sweden	Local Institution	Malmo
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Uppsala
Taiwan	Local Institution	Tainan
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taoyuan
United Kingdom	Local Institution	Hull
United Kingdom	Local Institution	Leeds	North Yorkshire
United Kingdom	Local Institution	Manchester
United States	Albuquerque Center For Rheumatology	Albuquerque	New Mexico
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Arthritis Clinic Of Northern Virginia, P.C.	Arlington	Virginia
United States	Joao Nascimento	Bridgeport	Connecticut
United States	Coeur D'Alene Arthrit Clin	Coeur d'Alene	Idaho
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Spectrum Medical, Inc.	Danville	Virginia
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	St. Paul Rheumatology, P.A.	Eagan	Minnesota
United States	Arthritis And Osteoporosis Associates, Pa	Freehold	New Jersey
United States	St. Joseph Heritage Medical Group	Fullerton	California
United States	Arizona Arthritis & Rheumatology Research PLLC	Glendale	Arizona
United States	Rheumatic Disease Center	Glendale	Wisconsin
United States	Klein And Associates, M.D., Pa	Hagerstown	Maryland
United States	Local Institution	Hickory	North Carolina
United States	CHI St. Vincent Medical Group Hot Springs	Hot Springs	Arkansas
United States	Houston Institute For Clinical Research	Houston	Texas
United States	Healthcare Partners Medical Group	Huntington Beach	California
United States	Rheumatology Associates Of North Alabama, P.C.	Huntsville	Alabama
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Physician Research Collaboration, Llc	Lincoln	Nebraska
United States	Arkansas Primary Care Clinic	Little Rock	Arkansas
United States	Valerius Medical Group and Research Center	Los Alamitos	California
United States	Arizona Arthritis & Rheumatology Research PLLC	Mesa	Arizona
United States	Arthritis And Diabetes Clinic	Monroe	Louisiana
United States	Hospital For Special Surgery	New York	New York
United States	Health Research Of Oklahoma	Oklahoma City	Oklahoma
United States	Rheumatology Associates Of Central Florida, P.A.	Orlando	Florida
United States	The Arthritis Group	Philadelphia	Pennsylvania
United States	Arizona Arthritis & Rheumatology Research PLLC	Phoenix	Arizona
United States	Arizona Arthritis & Rheumatology Research PLLC	Phoenix	Arizona
United States	Arthritis Consultants	Saint Louis	Missouri
United States	Pmg Research Of Salisbury	Salisbury	North Carolina
United States	Arthritis Northwest	Spokane	Washington
United States	Arizona Arthritis & Rheumatology Research PLLC	Sun City	Arizona
United States	Tampa Medical Group, Pa	Tampa	Florida
United States	Physicians Research Center, Llc	Toms River	New Jersey
United States	Oklahoma Ctr For Arthritis Therapy And Research, Inc.	Tulsa	Oklahoma
United States	Inland Rheumatology Clinical Trials Inc.	Upland	California
United States	Carolina Arthritis Associates	Wilmington	North Carolina
United States	Pmg Research Of Wilmington Llc	Wilmington	North Carolina
United States	Clinical Research Center Of Reading, Llp	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Canada,  Chile,  Colombia,  Czechia,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Monaco,  Netherlands,  Peru,  Poland,  Qatar,  Romania,  Russian Federation,  Singapore,  South Africa,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 24
Secondary	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.	Week 24
Secondary	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.	Week 52
Secondary	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.	Week 52
Secondary	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.	Week 52

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls