Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)
SIMPACT
Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)
1 other identifier
observational
353
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedStudy Start
First participant enrolled
May 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2018
CompletedDecember 6, 2019
December 1, 2019
3.6 years
March 25, 2015
December 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study
Baseline, end of study (up to 24 weeks)
Secondary Outcomes (15)
Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study
Baseline, end of study (up to 24 weeks)
Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (≤) 2.6
Up to 24 weeks
Percentage of Participants Achieving CDAI Remission, as Defined by CDAI ≤2.8
Up to 24 weeks
Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups
Baseline, end of study (up to 24 weeks)
Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6
Up to 24 weeks
- +10 more secondary outcomes
Study Arms (1)
Tocilizumab for RA in Routine Clinical Practice
Participants from routine clinical practice in Hungary who are receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling and who have no contraindication to tocilizumab therapy as per the local label are eligible for observation.
Interventions
Dosing and treatment duration of tocilizumab collected as part of this non-interventional study are at the discretion of the physician in accordance with local clinical practice and local labeling. Observation period is 24 weeks from first SC tocilizumab administration.
Eligibility Criteria
Participants receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current SPC/local labeling and who have no contraindication to tocilizumab therapy as per the local label. This can include participants who have received tocilizumab SC monotherapy treatment within 8 weeks prior to the enrollment visit.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
National Institute of Rheumatology and Physiotherapy; 4Th Rheumatology Department
Budapest, 1023, Hungary
Budai Irgalmasrendi Kórház KHT. II. Reumatológia
Budapest, 1027, Hungary
Magyar Honvedseg Honved Korhaz, Reumatologia
Budapest, 1062, Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
Debrecen, 4032, Hungary
Markhot Ferenc Hospital; Dep. of Rheumatology
Eger, 3300, Hungary
Vaszary Kolos Kórház
Esztergom, 2500, Hungary
Petz Aladár County Teaching Hospital
Győr, 9023, Hungary
Pandy Kalman Hospital; Dept. of Infectious Diseases
Gyula, 5700, Hungary
Szent Andras Reumakorhaz; Reumatologia
Hévíz, 8380, Hungary
Bacs-Kiskun Megyei Korhaz
Kecskemét, 6000, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2084, Hungary
Szent Ferenc Kórház; Reumatológia
Miskolc, 3529, Hungary
Szabolcs-Szatmar-Bereg Megyei Josa Andras Korhaz; Reumatologia
Nyíregyháza, 4400, Hungary
Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika
Pécs, 7632, Hungary
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont; Rheumatologiai Klinika
Szeged, 6724, Hungary
Fejér Megyei Szent György Kórház; Reumatológiai Osztály
Székesfehérvár, 8000, Hungary
Markusovszky Hospital
Szombathely, 9700, Hungary
Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia
Veszprém, 8200, Hungary
Related Publications (1)
Nagy G, Geher P, Tamasi L, Drescher E, Keszthelyi P, Pulai J, Czirjak L, Szekanecz Z, Kiss G, Kovacs L. Real-world evidence on methotrexate-free subcutaneous tocilizumab therapy in patients with rheumatoid arthritis: 24-week data from the SIMPACT study. Rheumatol Adv Pract. 2022 May 16;6(2):rkac038. doi: 10.1093/rap/rkac038. eCollection 2022.
PMID: 35663154DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2015
First Posted
March 30, 2015
Study Start
May 20, 2015
Primary Completion
December 17, 2018
Study Completion
December 17, 2018
Last Updated
December 6, 2019
Record last verified: 2019-12