NCT04369651

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

4.6 years

First QC Date

April 28, 2020

Last Update Submit

April 29, 2020

Conditions

Keywords

socio-economic determinantsbiologicNepallow income countryspondyloarthroathy

Outcome Measures

Primary Outcomes (1)

  • socio economic determinants

    socio economic determinants for acceptance of biologic therapy

    four years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with SpA and enrolled in the cohort database from June 2015 to December 2019 were selected.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study coordinator

Study Record Dates

First Submitted

April 28, 2020

First Posted

April 30, 2020

Study Start

June 1, 2015

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 1, 2020

Record last verified: 2020-04