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)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Tocilizumab

• Study Type: Observational
• Enrollment (Actual): 353

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1023
    • National Institute of Rheumatology and Physiotherapy; 4Th Rheumatology Department
  • Budapest, Hungary, 1027
    • Budai Irgalmasrendi Kórház KHT. II. Reumatológia
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Honved Korhaz, Reumatologia
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
  • Eger, Hungary, 3300
    • Markhot Ferenc Hospital; Dep. of Rheumatology
  • Esztergom, Hungary, 2500
    • Vaszary Kolos Kórház
  • Gyula, Hungary, 5700
    • Pandy Kalman Hospital; Dept. of Infectious Diseases
  • Győr, Hungary, 9023
    • Petz Aladár County Teaching Hospital
  • Heviz, Hungary, 8380
    • Szent Andras Reumakorhaz; Reumatologia
  • Kecskemet, Hungary, 6000
    • Bacs-Kiskun Megyei Korhaz
  • Kistarcsa, Hungary, 2084
    • Pest Megyei Flor Ferenc Korhaz
  • Miskolc, Hungary, 3529
    • Szent Ferenc Kórház; Reumatológia
  • Nyiregyhaza, Hungary, 4400
    • Szabolcs-Szatmar-Bereg Megyei Josa Andras Korhaz; Reumatologia
  • Pécs, Hungary, 7632
    • Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika
  • Szeged, Hungary, 6724
    • Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont; Rheumatologiai Klinika
  • Szekesfehervar, Hungary, 8000
    • Fejér Megyei Szent György Kórház; Reumatológiai Osztály
  • Szombathely, Hungary, 9700
    • Markusovszky Hospital
  • Veszprem, Hungary, 8200
    • Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: RoActemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study	Baseline, end of study (up to 24 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)
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
Number of Tocilizumab SC Injections per Participant During Observational Treatment Period		Up to 24 weeks
Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations		Up to 24 weeks
Percentage of Participants on SC Tocilizumab First Line Monotherapy		Up to 24 weeks
Percentage of Participants with Reasons for SC Tocilizumab Monotherapy		Up to 24 weeks
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
Percentage of Participants with Other DMARDs Than Methotrexate Before Tocilizumab Monotherapy Initiation and at End of Observation Period		Baseline, Week 24
Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study		Baseline, Week 24
Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period		Week 24
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
Percentage of Participants with Adverse Events		Up to 24 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2015
• Primary Completion (Actual): December 17, 2018
• Study Completion (Actual): December 17, 2018

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML29719