Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients

NCT03440892 | Unknown

• 1 other identifier: Survivin in Treatment
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

To validate the utility of survivin as a biomarker of pharmacological response to therapeutic intervention in rheumatoid arthritis patients.

Conditions

Rheumatoid Arthritis

Keywords

survivin; biomarker of pharmacological response; antirheumatic treatment; methotrexate; sulfasalazin; abatacept; tocilizumab; tofacitinib/baricitinib

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Disease activity (DAS28)

  6 months

• Response to treatment

  6 months

Study Arms (1)

1

Drug: methotrexate; Drug: sulfasalazine; Drug: abatacept; Drug: tocilizumab; Drug: tofacitinib/baricitinib

Interventions

methotrexate DRUG

folate antagonist

1

sulfasalazine DRUG

Immunomodulatory

Also known as: Salazopyrin

1

abatacept DRUG

Targeting CTLA-4 (fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4)

Also known as: Orencia

1

tocilizumab DRUG

IL-6 receptor antagonist

Also known as: RoActemra

1

tofacitinib/baricitinib DRUG

JAK inhibitor

Also known as: Xeljanz/Olumiant

1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rheumatoid arthritis patients

You may qualify if:

• Patients fulfilling the RA classification criteria according to the ACR/EULAR

You may not qualify if:

• Patients at stable/unchanged anti-rheumatic treatment
• Other serious physical or mental illness
• Lack of knowledge in Swedish making answering the questionnaires impossible

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Dept of Rheumatology and Inflammation research

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; Sulfasalazine; Abatacept; tocilizumab; tofacitinib; baricitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Central Study Contacts

Maria Bokarewa, MD

CONTACT

maria.bokarewa@rheuma.gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 22, 2018
• Study Start: November 1, 2017
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

SE (1)