Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Socio-economic Determinants for Acceptance and Choice of Biological Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369651
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Shweta Nakarmi, National Center for Rheumatic Diseases, Nepal

Tracking Information
First Submitted Date April 28, 2020
First Posted Date April 30, 2020
Last Update Posted Date May 1, 2020
Actual Study Start Date June 1, 2015
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2020)
socio economic determinants [ Time Frame: four years ]
socio economic determinants for acceptance of biologic therapy
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Socio-economic Determinants for Acceptance and Choice of Biological Treatment
Official Title Socio-economic Determinants for Acceptance and Choice of Biological Treatment by Patients With Spondyloarthropathy in Nepal
Brief Summary This was a cross-sectional study conducted at National center for rheumatic diseases, Nepal on SpA patient refractory to initial treatment with conventional anti rheumatic drugs. Patients taking TNFi (tumor necrosis factor inhibitor- adalimumab or etanercept) or tofacitinib were included. Baseline demographic, socio-economic, clinical data were recorded.
Detailed Description

This was a cross-sectional observational study conducted in the rheumatology clinic of National Center for Rheumatic Diseases, Kathmandu, Nepal. Patients with spondyloarthropathy (SpA) and enrolled in the cohort database from June 2015 to December 2019 were selected. Those taking any oral or injectable forms of biological treatment were included in the study. Patients less than 18 years of age, who did not consent for participation or additional information, who were deferred from biological treatment due to comorbid conditions like concurrent infections or heart failure were excluded. An informed consent was obtained from selected patients and any additional information required was taken via e-mail or telephone enquiry.

Diagnostic & measurement tools Diagnosis of SpA was made by rheumatologists on the basis of the modified New York Criteria for Ankylosing Spondylitis and the ASAS criteria (Assessment of SpondyloArthritis International Society) for axial and peripheral SpA. Diagnosis of nr-axial SpA was made by MRI evidence of sacroilitis in a patient with normal radiograph with or without HLA B27. Disease activity was assessed using composite Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

Socioeconomic status Socioeconomic factors studied were educational level and the primary occupation. Patient self-reported highest educational level was recorded and was categorized into illiterate, primary, secondary, higher secondary, above secondary level education. Occupation and social class were recorded based on self-report primary source of income. It was categorized into homemakers, students, service holders, business, teachers, farmers and others (field workers, labor workers). A dedicated research officer also took data on other demographic parameters and geographical location of residence. Geographical location was categorized into urban-rural and hilly-plain terrain.

Indications for offering biological treatment Indications for biological or small molecule treatment included: a. Failure of at least 2 courses of NSAIDS, b. Failure of at least 3months of conventional synthetic DMARDs (csDMARDs). For patients with PsA, the csDMARDs included methotrexate and/or leflunomide; for AS, nr-axial SpA and IBD-associated arthritis, it included sulfasalazine and/or methotrexate. Failure of treatment was defined as: a. Persistent ASDAS of ≥2.1, b. Improvement of ASDAS by less than -1.1, c. Persistent BASDAI of ≥4. All patients fulfilling these indications were offered biological treatment. Patients with no contraindication for TNFi were offered either injectable biologicals (adalimumab or etanercept: only TNFi available in Nepal) or tofacitinib (only small molecule available in Nepal) and explained about the preparatory investigations, dosage of TNFi, storage, cost, monitoring and side-effects.

Data collection and analysis Complete data on baseline demographic parameters (age, gender, address, education, occupation) and ASDAS and BASDAI scores at initiation of treatment with biological or small molecule were recorded in a hardcopy data-sheet and later entered to a predesigned excel-sheet by a trained research officer.

Statistical analysis was performed using SPSS version 21 (IBM Corp, USA). Simple descriptive statistics were used to analyze various socioeconomic and demographic parameters. Chi-squared test was used to analyze difference in these parameters between patients who chose injectable and those who chose tofacitinib. Linear regression analysis was performed to identify variables associated with use of any biological agent. All variables with p-value of <0.05 were analyzed in multiple regression model to evaluate the independent association. Difference in mean values between two treatment groups were assessed by independent t-test.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with SpA and enrolled in the cohort database from June 2015 to December 2019 were selected.
Condition Spondyloarthritis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 28, 2020)
117
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with spondyloarthropathy
  • on any oral or injectable forms of biological treatment

Exclusion Criteria:

  • less than 18years of age
  • who did not consent for participation
  • deferred from biological treatment due to comorbid conditions like concurrent infections or heart failure
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04369651
Other Study ID Numbers 210/2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Shweta Nakarmi, National Center for Rheumatic Diseases, Nepal
Study Sponsor National Center for Rheumatic Diseases, Nepal
Collaborators Not Provided
Investigators Not Provided
PRS Account National Center for Rheumatic Diseases, Nepal
Verification Date April 2020