Rheumatoid Arthritis Clinical Trial
— SIMPACTOfficial title:
Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)
NCT number | NCT02402686 |
Other study ID # | ML29719 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 20, 2015 |
Est. completion date | December 17, 2018 |
Verified date | December 2019 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.
Status | Completed |
Enrollment | 353 |
Est. completion date | December 17, 2018 |
Est. primary completion date | December 17, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Moderate to severe RA according to 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) joint criteria - Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label - Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate Exclusion Criteria: - Treatment with tocilizumab more than 8 weeks prior to enrollment - Failure to meet local tocilizumab label indication criteria - Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy - Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy - History of any other autoimmune or joint inflammatory disease |
Country | Name | City | State |
---|---|---|---|
Hungary | Budai Irgalmasrendi Kórház KHT. II. Reumatológia | Budapest | |
Hungary | Magyar Honvedseg Honved Korhaz, Reumatologia | Budapest | |
Hungary | National Institute of Rheumatology and Physiotherapy; 4Th Rheumatology Department | Budapest | |
Hungary | Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék | Debrecen | |
Hungary | Markhot Ferenc Hospital; Dep. of Rheumatology | Eger | |
Hungary | Vaszary Kolos Kórház | Esztergom | |
Hungary | Petz Aladár County Teaching Hospital | Gyor | |
Hungary | Pandy Kalman Hospital; Dept. of Infectious Diseases | Gyula | |
Hungary | Szent Andras Reumakorhaz; Reumatologia | Heviz | |
Hungary | Bacs-Kiskun Megyei Korhaz | Kecskemet | |
Hungary | Pest Megyei Flor Ferenc Korhaz | Kistarcsa | |
Hungary | Szent Ferenc Kórház; Reumatológia | Miskolc | |
Hungary | Szabolcs-Szatmar-Bereg Megyei Josa Andras Korhaz; Reumatologia | Nyiregyhaza | |
Hungary | Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika | Pécs | |
Hungary | Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont; Rheumatologiai Klinika | Szeged | |
Hungary | Fejér Megyei Szent György Kórház; Reumatológiai Osztály | Szekesfehervar | |
Hungary | Markusovszky Hospital | Szombathely | |
Hungary | Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia | Veszprem |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study | Baseline, end of study (up to 24 weeks) | ||
Secondary | Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study | Baseline, end of study (up to 24 weeks) | ||
Secondary | Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (=) 2.6 | Up to 24 weeks | ||
Secondary | Percentage of Participants Achieving CDAI Remission, as Defined by CDAI =2.8 | Up to 24 weeks | ||
Secondary | Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups | The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing disease-modifying antirheumatic drugs (DMARDs), 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics. | Baseline, end of study (up to 24 weeks) | |
Secondary | Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 =2.6 | The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics. | Up to 24 weeks | |
Secondary | Number of Tocilizumab SC Injections per Participant During Observational Treatment Period | Up to 24 weeks | ||
Secondary | Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations | Up to 24 weeks | ||
Secondary | Percentage of Participants on SC Tocilizumab First Line Monotherapy | Up to 24 weeks | ||
Secondary | Percentage of Participants with Reasons for SC Tocilizumab Monotherapy | Up to 24 weeks | ||
Secondary | Percentage of Participants Treated Previously with a Tumor Necrosis Factor (TNF) Inhibitor/Other Biologic and Low Dose Methotrexate (Less Than 10 Milligrams/Week) | Up to 24 weeks | ||
Secondary | Percentage of Participants with Other DMARDs Than Methotrexate Before Tocilizumab Monotherapy Initiation and at End of Observation Period | Baseline, Week 24 | ||
Secondary | Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study | Baseline, Week 24 | ||
Secondary | Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period | Week 24 | ||
Secondary | Percentage of Participants with Steroid Tapering in Different Monotherapy Subgroups Who Achieved DAS28 Remission | The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics. | Up to 24 weeks | |
Secondary | Percentage of Participants with Adverse Events | Up to 24 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |