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
Not provided
This observational study will evaluate the presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16 | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue | 16 months | |
| Disease Activity Score DAS28 | 16 months | |
| Pain: Visual Analogue Scale VAS Pain |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with moderate to severe rheumatoid arthritis with an inadequate response to at least two DMARDs or an inadequate response to anti-TNF treatment, eligible for treatment with RoActemra/Actemra
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | 9300 | Belgium | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26344671 | Derived | Gossec L, Steinberg G, Rouanet S, Combe B. Fatigue in rheumatoid arthritis: quantitative findings on the efficacy of tocilizumab and on factors associated with fatigue. The French multicentre prospective PEPS Study. Clin Exp Rheumatol. 2015 Sep-Oct;33(5):664-70. Epub 2015 Sep 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 16 months |
| Functional disability: Health Assessment Questionnaire HAQ | 16 months |
| Quality of sleep: VAS | 16 months |
| Anemia: Haemoglobin levels | 16 months |
| Depression: Beck Depression Inventory (BDI) questionnaire | 16 months |
| Assebroek |
| 8310 |
| Belgium |
| Ath | 7800 | Belgium |
| Brussels | 1000 | Belgium |
| Dinant | 5500 | Belgium |
| Gilly (Charleroi) | 6000 | Belgium |
| Kortrijk | 8500 | Belgium |
| Lier | 2500 | Belgium |
| Mons | 7000 | Belgium |
| Namur | 5000 | Belgium |
| Roeselare | 8800 | Belgium |
| Seraing | 4100 | Belgium |
| Sijsele | 8340 | Belgium |
| Turnhout | 2300 | Belgium |
| Verviers | 4800 | Belgium |
| Waremme | 4300 | Belgium |
| Westmalle | 2390 | Belgium |
| Luxembourg | 2763 | Luxembourg |
| 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