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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004017-17 | EudraCT Number | ||
| 14383 | Other Identifier | UKCRN |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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The TREMERA study focuses on patients with newly diagnosed, untreated, rheumatoid arthritis (RA). Recent international treatment recommendations emphasise the need to diagnose RA early and start treatment immediately (this being associated with better response rates); and to aim for the goal of remission i.e. the absence of signs and symptoms of active inflammatory disease activity which is associated with better outcomes for the patient. Remission is more achievable with significant treatment advances that have been made in the form of highly effective biologic therapies. Tocilizumab (TCZ) is a newly introduced biologic drug that is used in established RA. The TREMERA study primarily aims to investigate the biological changes seen in blood and tissue following TCZ therapy this will contribute to a better understanding of how the drug works as well as disease processes; and will also identify whether administering a biologic drug such as TCZ can also switch off immunological parameters associated with a disrupted immune system of RA. The study will assess the effectiveness of TCZ given on its own or in combination with methotrexate (MTX; a standard therapy usually given with biologic treatments)in patients with early onset RA to determine the proportion that achieve remission. This study also aims to find out how quickly remission can be achieved with TCZ and the depth of remission achieved. This will be done using usual clinical assessment but also imaging such as ultrasound and magnetic resonance imaging (MRI) which can detect inflammation not apparent on clinical assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCZ monotherapy | Experimental | Tocilizumab (TCZ) monotherapy 8mg/kg 4-weekly for a total of 48 weeks. |
|
| TCZ+MTX combination therapy | Experimental | Tocilizumab (TCZ) and methotrexate (MTX) combination therapy 8mg/kg 4-weekly for a total of 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug |
| ||
| Methotrexate |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate change in expression of JAK 1 and 3 (as well as STAT and p38 MAPK). | Changes up to week 60 | To week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in inflammation in each treatment arm using ultrasound | Establish reduction in inflammation in each treatment arm using ultrasound using grey scale power doppler | To week 48 |
| Disease Activity Score (DAS): DAS28/44 remission |
| Measure | Description | Time Frame |
|---|---|---|
| MRI sub-study (separately consented) - optional | Establish if reduction in RA MRI Scoring system (RAMRIS) synovitis score | To week 48 |
| Cardiovascular sub-study (separately consented) - optional | Change in cardiovascular measures on cardiac MRI and serum biomarkers |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Maya H Buch | University of Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust | Leeds | West Yorkshire | LS7 4SA | United Kingdom |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Drug |
|
Proportion of patients achieving DAS28/44 remission
| To week 48 |
| Questionnaires and research tools | Using tools including DAS28/44, SDAI, CDAI | Week 48 |
| Health Assessment Questionniaire (HAQ) scores | The change from baseline in HAQ scores. | To week 48 |
| VAS scores questionnaire | The change in VAS scores for pain, disease activity | To week 48 |
| Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire | The change in RAQoL from baseline | To week 48 |
| Bone densitometry | Bone densitometry scan of hands, spine, femoral neck | Week 48. |
| Sharp score on plain radiographs | Change in modified Sharp score on plain radiographs | Week 48. |
| To week 48 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |