Clinical trial NCT02402686: Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)
Official title: Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study
timeFrame: Baseline, end of study (up to 24 weeks)
Secondary outcomes:
measure: Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study
timeFrame: Baseline, end of study (up to 24 weeks)
measure: Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (≤) 2.6
timeFrame: Up to 24 weeks
measure: Percentage of Participants Achieving CDAI Remission, as Defined by CDAI ≤2.8
timeFrame: Up to 24 weeks
measure: Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups
timeFrame: Baseline, end of study (up to 24 weeks)
measure: Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6
timeFrame: Up to 24 weeks
measure: Number of Tocilizumab SC Injections per Participant During Observational Treatment Period
timeFrame: Up to 24 weeks
measure: Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations
timeFrame: Up to 24 weeks
measure: Percentage of Participants on SC Tocilizumab First Line Monotherapy
timeFrame: Up to 24 weeks
measure: Percentage of Participants with Reasons for SC Tocilizumab Monotherapy
timeFrame: Up to 24 weeks
measure: Percentage of Participants Treated Previously with a Tumor Necrosis Factor (TNF) Inhibitor/Other Biologic and Low Dose Methotrexate (Less Than 10 Milligrams/Week)
timeFrame: Up to 24 weeks
measure: Percentage of Participants with Other DMARDs Than Methotrexate Before Tocilizumab Monotherapy Initiation and at End of Observation Period
timeFrame: Baseline, Week 24
measure: Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study
timeFrame: Baseline, Week 24
measure: Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period
timeFrame: Week 24
measure: Percentage of Participants with Steroid Tapering in Different Monotherapy Subgroups Who Achieved DAS28 Remission
timeFrame: Up to 24 weeks
measure: Percentage of Participants with Adverse Events
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Institute of Rheumatology and Physiotherapy; 4Th Rheumatology Department
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Kórház KHT. II. Reumatológia
city: Budapest
country: Hungary
facility: Magyar Honvedseg Honved Korhaz, Reumatologia
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
city: Eger
country: Hungary
facility: Markhot Ferenc Hospital; Dep. of Rheumatology
city: Esztergom
country: Hungary
facility: Vaszary Kolos Kórház
city: Gyula
country: Hungary
facility: Pandy Kalman Hospital; Dept. of Infectious Diseases
city: Győr
country: Hungary
facility: Petz Aladár County Teaching Hospital
city: Heviz
country: Hungary
facility: Szent Andras Reumakorhaz; Reumatologia
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Miskolc
country: Hungary
facility: Szent Ferenc Kórház; Reumatológia
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Josa Andras Korhaz; Reumatologia
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ: Immunológiai és Reumatológiai Klinika
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont; Rheumatologiai Klinika
city: Szekesfehervar
country: Hungary
facility: Fejér Megyei Szent György Kórház; Reumatológiai Osztály
city: Szombathely
country: Hungary
facility: Markusovszky Hospital
city: Veszprem
country: Hungary
facility: Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.