Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)
- Registration Number
- NCT02402686
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tocilizumab for RA in Routine Clinical Practice Tocilizumab 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.
- Primary Outcome Measures
Name Time Method Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study Baseline, end of study (up to 24 weeks)
- Secondary Outcome Measures
Name Time Method 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 Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6 Up to 24 weeks 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.
Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period Week 24 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 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 with Reasons for SC Tocilizumab Monotherapy Up to 24 weeks Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study Baseline, Week 24 Percentage of Participants with Adverse Events 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) 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.
Number of Tocilizumab SC Injections per Participant During Observational Treatment Period 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 Steroid Tapering in Different Monotherapy Subgroups Who Achieved DAS28 Remission Up to 24 weeks 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.
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
Trial Locations
- Locations (18)
National Institute of Rheumatology and Physiotherapy; 4Th Rheumatology Department
🇭🇺Budapest, Hungary
Budai Irgalmasrendi Kórház KHT. II. Reumatológia
🇭🇺Budapest, Hungary
Szent Andras Reumakorhaz; Reumatologia
🇭🇺Heviz, Hungary
Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia
🇭🇺Veszprem, Hungary
Magyar Honvedseg Honved Korhaz, Reumatologia
🇭🇺Budapest, Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék
🇭🇺Debrecen, Hungary
Pandy Kalman Hospital; Dept. of Infectious Diseases
🇭🇺Gyula, Hungary
Petz Aladár County Teaching Hospital
🇭🇺Győr, 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
Markhot Ferenc Hospital; Dep. of Rheumatology
🇭🇺Eger, Hungary
Vaszary Kolos Kórház
🇭🇺Esztergom, Hungary