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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02675426
Other study ID # M13-549
Secondary ID 2015-003332-13
Status Completed
Phase Phase 3
First received
Last updated
Start date December 17, 2015
Est. completion date March 10, 2022

Study information

Verified date March 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.


Description:

This Phase 3 multicenter study includes two periods. Period 1 is a 12-week, randomized, double-blind, parallel-group, placebo-controlled period designed to compare the safety and efficacy of upadacitinib 30 mg once daily and upadacitinib 15 mg once daily versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis (RA) who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs. Period 2 is a 248-week blinded long-term extension period to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 30 mg once daily and upadacitinib 15 mg once daily in participants who completed Period 1. Participants were to be randomized in a 2:2:1:1 ratio using interactive response technology (IRT) to receive double-blind study drug in one of the following treatment groups: - Group 1: Upadacitinib 30 mg QD in Period 1 → Upadacitinib 30 mg QD in Period 2 - Group 2: Upadacitinib 15 mg QD in Period 1 → Upadacitinib 15 mg QD in Period 2 - Group 3: Placebo in Period 1 → Upadacitinib 30 mg QD in Period 2 - Group 4: Placebo in Period 1 → Upadacitinib 15 mg QD in Period 2 Randomization was stratified by prior exposure to biological disease-modifying anti-rheumatic drug (bDMARD) (yes/no) and geographic region. Following Protocol Amendment 6.0 approval in December 2019, all participants still on study received open-label upadacitinib 15 mg QD, including those on upadacitinib 30 mg QD, with the earliest switch occurring at the Week 168 visit.


Recruitment information / eligibility

Status Completed
Enrollment 661
Est. completion date March 10, 2022
Est. primary completion date April 21, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult male or female, at least 18 years old. - Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months. - Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. - Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits. - Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods. Exclusion Criteria: - Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). - History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted. - Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Tablet; Oral
Upadacitinib
Tablet; Oral

Locations

Country Name City State
Argentina Mautalen Salud e Investigacion /ID# 141419 Buenos Aires
Argentina Inst. Rheumatologic Strusberg /ID# 145648 Cordoba
Australia Emeritus Research /ID# 138773 Camberwell Victoria
Australia Coffs Clinical Trials /ID# 138747 Coffs Harbour New South Wales
Australia Barwon Rheumatology /ID# 138772 Geelong Victoria
Australia Optimus Clinical Research Pty. /ID# 138769 Kogarah New South Wales
Austria Rheuma Zentrum Favoriten GmbH /ID# 138787 Vienna
Austria Wilhelminenspital der Stadt Wien /ID# 138788 Wien
Belgium AZ Sint Lucas /ID# 141338 Brugge
Belgium Rhumaconsult SPRL /ID# 138813 Charleroi Hainaut
Belgium UZ Gent /ID# 138806 Gent Oost-Vlaanderen
Bosnia and Herzegovina University Clinical Centre of the Republic of Srpska /ID# 138819 Banja Luka Republika Srpska
Bosnia and Herzegovina University Clinical Centre of the Republic of Srpska /ID# 140372 Banja Luka Republika Srpska
Bulgaria Diag Consult Ctr 17 Sofia EOOD /ID# 141006 Sofia
Bulgaria Diagnostic Consultative Center /ID# 138882 Sofia
Canada Groupe de Recherche en Maladies Osseuses /ID# 138906 Sainte-foy Quebec
Canada Dr. Latha Naik /ID# 139089 Saskatoon Saskatchewan
Canada Eastern Health /ID# 140431 St. John's Newfoundland and Labrador
Canada Manitoba Clinic /ID# 139086 Winnipeg Manitoba
Croatia Klinicki bolnicki centar Rijeka /ID# 138649 Rijeka Primorsko-goranska Zupanija
Croatia Klinicka bolnica Sveti Duh /ID# 152812 Zagreb
Croatia Medical Center Kuna-Peric /ID# 140365 Zagreb
Croatia Poliklinika Bonifarm /ID# 141415 Zagreb
Czechia Revmatologie, s.r.o. /ID# 138899 Brno
Czechia L.K.N. Arthrocentrum, s.r.o /ID# 141340 Hlucín Moravskoslezsky Kraj
Czechia Artroscan s.r.o. /ID# 138833 Ostrava
Czechia Nemocnice Slany /ID# 141112 Slany
Czechia PV-MEDICAL s.r.o. /ID# 138913 Zlin
Estonia Paernu Hospital /ID# 138961 Pärnu
Estonia Center of Clinical and Basic Research /ID# 141116 Tallinn Harjumaa
Estonia East Tallinn Central Hospital /ID# 140618 Tallinn
Finland Helsinki Univ Central Hospital /ID# 140381 Helsinki
Finland Kiljava Medical Research /ID# 139260 Hyvinkaa
Finland South Karelia Central Hospital /ID# 139973 Lappeenranta
France CHRU Tours - Hopital Trousseau /ID# 138969 Chambray Les Tours
France Hopital Saint Joseph /ID# 149188 Marseille CEDEX 08 Bouches-du-Rhone
Germany Charité Universitätsmedizin Campus Mitte /ID# 139052 Berlin
Germany Immanuel-Krankenhaus /ID# 139059 Berlin
Germany Asklepios Klinik Altona /ID# 140466 Hamburg
Germany Uniklinik Koln /ID# 139084 Köln Nordrhein-Westfalen
Germany Welcker, Planegg, DE /ID# 140467 Planegg
Greece University General Hospital of Heraklion "PA.G.N.I" /ID# 139115 Heraklion
Hong Kong Prince of Wales Hospital /ID# 139314 Sha Tin
Hungary Revita Reumatologiai Rendelo /ID# 140761 Budapest
Hungary Fejer Megyei Szent Gyorgy Korh /ID# 138554 Szekesfehervar
Ireland St Vincent's University Hosp /ID# 138562 Dublin
Italy Universita di Catanzaro Magna Graecia /ID# 139316 Catanzaro Calabria
Kazakhstan JSC Nat Scientific Med Res Ctr /ID# 140575 Astana
Korea, Republic of Daegu Catholic University Med /ID# 139249 Daegu
Korea, Republic of Chungnam National University Hospital /ID# 138653 Daejeon
Korea, Republic of Chonnam National University Hospital /ID# 138651 Gwangju Jeonranamdo
Korea, Republic of Inha University Hospital /ID# 149310 Incheon Gwang Yeogsi
Korea, Republic of Asan Medical Center /ID# 140579 Seoul
Korea, Republic of Cath Univ Seoul St Mary's Hosp /ID# 138652 Seoul Seoul Teugbyeolsi
Korea, Republic of Hanyang University Seoul Hospi /ID# 138655 Seoul Seongdong-gu
Korea, Republic of Seoul National University Hospital /ID# 138659 Seoul
Korea, Republic of Ajou University Hospital /ID# 149311 Suwon-si Gyeonggido
Latvia LTD M+M Centers /ID# 138818 Adazi
Lithuania Klaipeda University Hospital /ID# 141416 Klaipeda
Lithuania Vilnius University Hospital /ID# 141348 Vilnius
Mexico Centro Peninsular de Investigación Clínica SCP /ID# 148160 Colonia Centro Yucatan
Mexico Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 138841 Mexico City
New Zealand Porter Rheumatology Ltd /ID# 138347 Nelson
Poland Osteo-Medic spolka cywilna /ID# 138371 Bialystok Podlaskie
Poland NZOZ Centrum Reumatologiczne /ID# 138353 Elblag Warminsko-mazurskie
Poland McBk Sc /Id# 138360 Grodzisk Mazowiecki Mazowieckie
Poland NZOZ Nasz Lekarz /ID# 138374 Torun Kujawsko-pomorskie
Poland Rheuma Medicus /ID# 138372 Warsaw
Portugal Centro Hospitalar Lisboa Ocidental, EPE /ID# 140594 Lisbon Lisboa
Portugal Instituto Portugues De Reumatologia /ID# 148315 Lisbon Lisboa
Puerto Rico School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139328 San Juan
Romania Spitalul Clinic Judetean de Urgenta /ID# 138407 Cluj
Romania Spitalul Municipal Ploiesti /ID# 138405 Ploiesti
Romania Spitalul Clinic Judetean de Ur /ID# 138393 Sibiu
Russian Federation Kazan State Medical University /ID# 138413 Kazan Tatarstan, Respublika
Russian Federation Republican Clin Hos n.a. Baran /ID# 139273 Petrozavodsk
Russian Federation LLC Novaya Klinika /ID# 139269 Pyatigorsk Stavropol Skiy Kray
Russian Federation Samara Regional Clinical Hosp /ID# 148642 Samara
Russian Federation Ulyanovsk Regional Clin Hosp /ID# 139279 Ulyanovsk
Russian Federation Voronezh State Medical Univers /ID# 148431 Voronezh
Russian Federation Yaroslavi State Medical Univer /ID# 139908 Yaroslavl
Slovakia ARTROMAC n.o. /ID# 138428 Kosice
Slovakia Nemocnica Kosice Saca, a.s. /ID# 138918 Kosice
Slovakia Narodny ustav reumatickych chorob Piestany /ID# 138427 Pieštany
Slovakia Slovak research center Team Member, Thermium s.r.o. /ID# 139924 Pieštany
Slovakia REUMA-GLOBAL, s.r.o. /ID# 139912 Trnava
South Africa St. Augustine's Medical Centre /ID# 141352 Berea Kwazulu-Natal
South Africa Arthritis Clinical Research Tr /ID# 138945 Cape Town Western Cape
South Africa Winelands Medical Research Ctr /ID# 138944 Stellenbosch Western Cape
Spain Hospital General Univ de Elche /ID# 138991 Elche
Spain Hospital Clin Univ San Carlos /ID# 138993 Madrid
Spain Hospital Regional de Malaga /ID# 138975 Málaga Malaga
Spain Hosp Nuestra Senora Esperanza /ID# 138997 Santiago de Compostela
Switzerland HFR Fribourg - Hopital Canton /ID# 139155 Fribourg
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 140869 Kaohsiung
Taiwan Far Eastern Memorial Hospital /ID# 140871 New Taipei City
Taiwan China Medical University Hosp /ID# 139232 Taichung City Taichung
Taiwan National Cheng Kung University Hospital /ID# 140868 Tainan City Tainan
Taiwan National Taiwan Univ Hosp /ID# 141443 Taipei City Taipei
Taiwan Taipei Veterans General Hosp /ID# 139234 Taipei City
Turkey Ankara Numune Training and Res /ID# 139237 Ankara
Ukraine LLC Revmocentr /ID# 139872 Kyiv
Ukraine MNCE "Lviv City Clinical Hospital #4" /ID# 139873 Lviv
Ukraine Odessa National Medical Univ /ID# 139179 Odesa
United Kingdom Western General Hospital /ID# 139524 Edinburgh
United Kingdom Leicester Royal Infirmary /ID# 139184 Leicester England
United Kingdom The Royal Free Hospital /ID# 139191 London London, City Of
United Kingdom Whipps Cross Univ Hospital /ID# 139523 London London, City Of
United Kingdom Southampton General Hospital /ID# 139169 Southampton
United Kingdom Warrington + Halton Hosp NHS /ID# 139195 Warrington
United States The Center for Rheumatology /ID# 138746 Albany New York
United States Tekton Research, Inc. /ID# 141428 Austin Texas
United States Western Washington Arthritis C /ID# 138728 Bothell Washington
United States Trinity Universal Res Assoc /ID# 149271 Carrollton Texas
United States Cincinnati Rheumatic Disease Study Group, Inc. /ID# 138868 Cincinnati Ohio
United States Clinical Res of West FL, Inc. /ID# 138854 Clearwater Florida
United States Arth and Osteo Clin Brazo Valley /ID# 147809 College Station Texas
United States Covina Arthritis Clinic /ID# 139881 Covina California
United States Metroplex Clinical Research /ID# 138698 Dallas Texas
United States Denver Arthritis Clinic /ID# 139876 Denver Colorado
United States Altoona Ctr Clinical Res /ID# 138741 Duncansville Pennsylvania
United States T. Joseph Raoof, MD, Inc. /ID# 140964 Encino California
United States Aurora Rheumatology and Immunotherapy Center /ID# 139306 Franklin Wisconsin
United States Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 141021 Hendersonville Tennessee
United States Baylor College of Medicine /ID# 138682 Houston Texas
United States Houston Institute for Clin Res /ID# 138716 Houston Texas
United States Institute of Arthritis Res /ID# 138548 Idaho Falls Idaho
United States Indiana Univ School of Med /ID# 140077 Indianapolis Indiana
United States Arthritis Consultants, P.A. /ID# 141138 Killeen Texas
United States Allergy and Rheum Med Clin /ID# 146082 La Jolla California
United States Advanced Rheumatology, PC /ID# 140071 Lansing Michigan
United States Justus J. Fiechtner, MD, PC /ID# 138697 Lansing Michigan
United States Bluegrass Community Research /ID# 138295 Lexington Kentucky
United States Physician Res. Collaboration /ID# 138533 Lincoln Nebraska
United States Pacific Arthritis Ctr Med Grp /ID# 138744 Los Angeles California
United States Mansfield Health Center /ID# 141357 Mansfield Massachusetts
United States AZ Arthritis and Rheum Assoc /ID# 148651 Mesa Arizona
United States Ctr Arthritis & Rheumatic Dise /ID# 141696 Miami Florida
United States Medallion Clinical Research Institute, LLC /ID# 140074 Naples Florida
United States Suncoast Clinical Research /ID# 138633 New Port Richey Florida
United States Health Research Oklahoma /ID# 138535 Oklahoma City Oklahoma
United States Westroads Clinical Research /ID# 138304 Omaha Nebraska
United States Omega Research Consultants /ID# 139877 Orlando Florida
United States Four Rivers Clinical Research /ID# 141134 Paducah Kentucky
United States Arthritis Center, Inc. /ID# 141363 Palm Harbor Florida
United States SunValley Arthritis Center, Lt /ID# 140452 Peoria Arizona
United States Arizona Research Center, Inc. /ID# 140448 Phoenix Arizona
United States AZ Arthritis & Rheuma Research /ID# 138598 Phoenix Arizona
United States AZ Arthritis and Rheum Researc /ID# 138500 Phoenix Arizona
United States AZ Arthritis and Rheum Researc /ID# 139286 Phoenix Arizona
United States Trinity Universal Research Association /ID# 148649 Plano Texas
United States MMP Women's Health /ID# 141542 Portland Maine
United States OrthoIllinois /ID# 139695 Rockford Illinois
United States PMG Research of Salisbury /ID# 141023 Salisbury North Carolina
United States Accurate Clinical Management /ID# 139338 San Antonio Texas
United States Clinical Investigation Special /ID# 139696 Skokie Illinois
United States Arthritis Northwest, PLLC /ID# 138539 Spokane Washington
United States Springfield Clinic /ID# 138602 Springfield Illinois
United States Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 138689 Summerville South Carolina
United States Arthritis Assoc of NW Ohio /ID# 140953 Toledo Ohio
United States University of Arizona Cancer Center - North Campus /ID# 140451 Tucson Arizona
United States Robin K. Dore MD, Inc /ID# 138688 Tustin California
United States Inland Rheum Clin Trials Inc. /ID# 138853 Upland California
United States Deerbrook Medical Associates /ID# 139694 Vernon Hills Illinois
United States Arthritis & Osteoporosis Clinic /ID# 138703 Waco Texas
United States The Center for Rheumatology & /ID# 139203 Wheaton Maryland
United States PMG Research of Wilmington LLC /ID# 140951 Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Croatia,  Czechia,  Estonia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Italy,  Kazakhstan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (1)

Burmester GR, Kremer JM, Van den Bosch F, Kivitz A, Bessette L, Li Y, Zhou Y, Othman AA, Pangan AL, Camp HS. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
= 20% improvement in 68-tender joint count;
= 20% improvement in 66-swollen joint count; and
= 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).
Baseline and Week 12
Primary Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of = 3.2 at Week 12.
The DAS28 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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
A DAS28 score less than or equal to 3.2 indicates low disease activity.
Week 12
Secondary Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12 The DAS28 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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity. Baseline and Week 12
Secondary Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
Baseline and Week 12
Secondary Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary (PCS) Score at Week 12 The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component summary score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.
Baseline and Week 12
Secondary Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12 Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.
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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Week 12
Secondary Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12 Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score = 10.
CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.
Week 12
Secondary Change From Baseline in Duration of Morning Stiffness at Week 12 Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. Baseline and Week 12
Secondary Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12 The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a five point Likert scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement. Baseline and week 12
Secondary Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
= 50% improvement in 68-tender joint count;
= 50% improvement in 66-swollen joint count; and
= 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).
Baseline and Week 12
Secondary Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
= 70% improvement in 68-tender joint count;
= 70% improvement in 66-swollen joint count; and
= 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).
Baseline and Week 12
Secondary Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1 Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
= 20% improvement in 68-tender joint count;
= 20% improvement in 66-swollen joint count; and
= 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).
Baseline and Week 1
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