Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis Clinical Trial

— SIMPACT  

Official title:

Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402686
• Other study ID #: ML29719
• Status: Completed
• Start date: May 20, 2015
• Est. completion date: December 17, 2018

Study information

• Verified date: December 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tocilizumab
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

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