- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03440892
Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients (SurviTreat)
Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Maria Bokarewa, MD
- Email: maria.bokarewa@rheuma.gu.se
Study Locations
-
-
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Gothenburg, Sweden
- Recruiting
- Dept of Rheumatology and Inflammation research
-
Contact:
- Sofia T Silfverswärd
- Email: sofia.silfversward@rheuma.gu.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients fulfilling the RA classification criteria according to the ACR/EULAR
Exclusion Criteria:
- Patients at stable/unchanged anti-rheumatic treatment
- Other serious physical or mental illness
- Lack of knowledge in Swedish making answering the questionnaires impossible
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
|
folate antagonist
Immunomodulatory
Other Names:
Targeting CTLA-4 (fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4)
Other Names:
IL-6 receptor antagonist
Other Names:
JAK inhibitor
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survivin status
Time Frame: 6 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease activity (DAS28)
Time Frame: 6 months
|
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 |
6 months
|
Response to treatment
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Dermatologic Agents
- Protein Kinase Inhibitors
- Immune Checkpoint Inhibitors
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Abatacept
- Tofacitinib
- Sulfasalazine
Other Study ID Numbers
- Survivin in Treatment
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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