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To validate the utility of survivin as a biomarker of pharmacological response to therapeutic intervention in rheumatoid arthritis patients.
In a prospective observational study the investigators aim to study the ability of modern antirheumatic treatments to suppress levels of survivin in sera. Rheumatoid arthritis patients scheduled to start new pharmacological treatment will be followed for a period of 6 months. No intervention or influence on choice of treatment will be performed, the decision of new/other medication is entirely made by the patient and their rheumatologist. The study entails addition of survivin analyse (1 vial of sera) before and after start of new treatment. Data concerning survivin levels, disease activity and other clinical parameters before and after start of new treatment will also be analysed. The patients will leave sera for survivin analyse at baseline and 3 and 6 months after start of new treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methotrexate | Drug | folate antagonist |
| |
| sulfasalazine |
| Measure | Description | Time Frame |
|---|---|---|
| Survivin status | Patients with a survivin level of over 0.45 ng/ml are considered to be survivin positive. Patients with survivin levels under 0.45 ng/ml are considered to be survivin negative A change from survivin positive to survivin negative (or vice versa) equals conversion of survivin status. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity (DAS28) | Disease activity, DAS28, is calculated using a specific formula based on:
DAS thresholds: DAS28 below 3.2: low disease activity DAS28 over 3.2 and under 5.1: moderate disease activity DAS28 above 5.1: high disease activity DAS28 lower than 2.6: remission |
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Inclusion Criteria:
Exclusion Criteria:
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Rheumatoid arthritis patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Bokarewa, MD | Contact | maria.bokarewa@rheuma.gu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Rheumatology and Inflammation research | Recruiting | Gothenburg | Sweden |
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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 |
|---|---|
| D008727 | Methotrexate |
| D012460 | Sulfasalazine |
| D000069594 | Abatacept |
| C502936 | tocilizumab |
| C479163 | tofacitinib |
| C000596027 | baricitinib |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Drug |
Immunomodulatory |
|
|
| abatacept | Drug | Targeting CTLA-4 (fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4) |
|
|
| tocilizumab | Drug | IL-6 receptor antagonist |
|
|
| tofacitinib/baricitinib | Drug | JAK inhibitor |
|
|
| 6 months |
| Response to treatment | The EULAR response criteria classify patients as good, moderate, or non-responders, using the change in DAS28 and the level of DAS28 reached. A patient must show a significant change as well as low disease activity to be classified as a good responder. Good responder: DAS28 scores ≤ 3.2 with reductions in DAS28 >1.2 Moderate responder: DAS28 scores > 3.2 with reductions in DAS28 >1.2 Non-responder: reductions in DAS28 ≤ 0.6 | 6 months |
| 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 |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |