Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous Tocilizumab | Participants receiving treatment for rheumatoid arthritis (RA) with subcutaneous Tocilizumab alone or in combination with conventional disease-modifying antirheumatic drugs (DMARDs) according to approved label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Biological | Subcutaneous Tocilizumab according to approved label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation | At 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health Assessment Questionnaire (HAQ) Score | At baseline, 24 and 52 weeks | |
| Visual Analog Scale (VAS) Pain Score in a 100 mm Scale | At baseline, 24 and 52 weeks | |
Not provided
Inclusion Criteria:
- Aged >/= 18 years of age with rheumatoid arthritis (RA) for whom the treating physician has made the decision to start subcutaneous (SC) Tocilizumab (TCZ) treatment according to approved label within 4 weeks prior to enrolment.
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants with rheumatoid arthritis for whom the physician has made the decision to start subcutaneous Tocilizumab treatment.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice Rheumatology, Merantzis | Agrinio | 301 00 | Greece | |||
| Rheumatology Private Practice |
Not provided
Not provided
Not provided
Not provided
| Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale |
| At baseline, 24 and 52 weeks |
| Percentage of Participants with Clinically Significant Changes in Laboratory Values | At baseline, 24 and 52 weeks |
| Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy | At baseline, 24 and 52 weeks |
| Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs) | At baseline, 24 and 52 weeks |
| Percentage of Participants with Adverse Events (AEs), including Serious Adverse Events (SAEs), Non-Serious Adverse Drug Reactions (nsADRs), Injection Site Reactions (ISRs), and Adverse Events of Special Interest (AESIs) | Up to 52 weeks |
| Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs | Up to 52 weeks |
| Percentage of Participants with IEs with Laboratory Abnormalities | Up to 52 weeks |
| Percentage of Participants with Dose Modification of Methotrexate (MTX) or Other Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) Due to AEs or IEs | Up to 52 weeks |
| Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs | Up to 52 weeks |
| Percentage of Participants on Glucocorticoids (GCs) with AEs | Up to 52 weeks |
| Disease Activity Score 28 (DAS28) | At baseline, 24 and 52 weeks |
| Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR) | At baseline, 24 and 52 weeks |
| Athens |
| 11521 |
| Greece |
| General Hospital of Athens KAT, Rheumatology | Athens | 14527 | Greece |
| Rheumatology Private Practice | Athens | Greece |
| Private Practice Rheumatology, Stavropoulos | Áno Patísia | Greece |
| Rheumatology Private Practice | Chania | 731 00 | Greece |
| Private Practice Rheumatology, Papadimitriou | Drama | 66132 | Greece |
| Rheumatology Private Practice | Eleusina | 19200 | Greece |
| ATTIKO Hospital_4th University Internal Medicine Clinic | Haidari | 124 62 | Greece |
| Private Practice Rheumatology, Georgiadis | Ioannina | 453 33 | Greece |
| Rheumatology Private Practice | Kalithea, Athens | 17673 | Greece |
| Private Practice Rheumatology, Kotrotsios | Karditsa | 431 00 | Greece |
| General Hospital of Kavala; Rheumatology | Kavala | 65500 | Greece |
| Rheumatology Private Practice | Kifissia | Greece |
| Private Practice Rehumatology, Ziogas | Larissa | 412 21 | Greece |
| General Hospital of Mytilini, Rheumatology | Mytilene | 811 00 | Greece |
| Private Practice Rheumatology, Trontzas | Néa Smýrni | 171 21 | Greece |
| Rheumatology Private Practice | Pátrai | 26221 | Greece |
| Olympion Medical Center of Patras, Internal Medicine Clinic | Pátrai | 26443 | Greece |
| Private Practice Rheumatology, Psaltis | Serres | 621 22 | Greece |
| Rheumatology Private Practice | Serres | 62122 | Greece |
| Rheumatology Private Practice | Thessaloniki | 54621 | Greece |
| General Hospital Agios Pavlos | Thessaloniki | Greece |
| Rheumatology Private Practice | Thessaloniki | Greece |
| Rheumatology Private Practice | Véroia | 59100 | Greece |
| Rheumatology Private Practice | Volos | 38221 | Greece |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided