NCT02948608

Brief Summary

The objective of the study is to investigate extra-articular manifestations, pain mechanisms, patient-reported outcomes, comorbidities and association between these conditions in patients with spondyloarthropathy (SpA) treated with Biologics. Further, to assess the predictive value of baseline pain profile on treatment outcome after ≥ 3 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

2.1 years

First QC Date

October 26, 2016

Last Update Submit

March 6, 2019

Conditions

Spondyloarthropathy

Keywords

spondyloarthropathyankylosing spondylitisspinal diseasesspondylitisspondylarthritispsoriasisuveitisjoint diseases

Outcome Measures

Primary Outcomes (1)

  • Ankylosing Spondylitis Disease Activity Index BASDAI 50 %

    composite measures of improvement in disease state (50% improvement)

    ≥ 3 month from baseline

Secondary Outcomes (1)

  • Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)

    ≥ 3 month from baseline

Other Outcomes (14)

  • To analyse the influence of PDQ score on the treatment response

    ≥ 3 month from baseline

  • Characterisation of the extra-articular manifestations in SpA patients

    at baseline and ≥ 3 months from baseline

  • Change in Bath Akylosing Spondylitis Functional Index (BASFI)

    ≥ 3 month from timeline

  • +11 more other outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

≥ 18 years and diagnosed with any disease of the SpA spectrum, and about to initiate or switch biological treatment. We use the Assessment of Spondyloarthritis International Society (ASAS) criteria for SpA, and the Modified New York criteria for ankylosing spondylitis

You may qualify if:

  • Patients diagnosed with SpA
  • ≥18 years of age at time of consent
  • Ability and willingness to give written informed consent and to meet the requirements of this protocol
  • Patients must have a history of active disease and a BASDAI \>40 (10-100) or elevated C-reactive protein, despite current or previous NSAIDs therapy

You may not qualify if:

  • Age \< 18 years
  • No consent
  • Pregnancy
  • Active or latent TB
  • Diagnosed Human immunodeficiency virus
  • Diagnosed hepatitis
  • Current or past malignant disease
  • Recurrent or chronic infection (viral, fungal or bacterial)
  • Multiple sclerosis
  • Heart failure (NYHA class III/IV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital, Svendborg Hospital

Svendborg, 5700, Denmark

Location

Related Publications (1)

  • Andreasen RA, Kristensen LE, Ellingsen T, Christensen R, Baraliakos X, Wied J, Aalykke C, Ulstrup T, Schiottz-Christensen B, Horn HC, Emamifar A, Duerlund B, Fischer L, Hansen IMJ. Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study. BMJ Open. 2017 Jul 10;7(7):e015536. doi: 10.1136/bmjopen-2016-015536.

    PMID: 28698330DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A Biobank will be established in connection with the routine blood samples taken at baseline (\~ 90 ml). The blood samples will be handled and registered by research laboratory technicians at the laboratory department, and stored at Odense University Hospital, Denmark (in the cold store)

MeSH Terms

Conditions

SpondylarthropathiesSpondylitis, AnkylosingSpinal DiseasesSpondylitisSpondylarthritisPsoriasisUveitisJoint Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesArthritisAxial SpondyloarthritisAnkylosisBone Diseases, InfectiousInfectionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesUveal DiseasesEye Diseases

Study Officials

  • Inger Marie J Hansen, MD, DmSci

    Svendborg Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 28, 2016

Study Start

March 1, 2017

Primary Completion

March 31, 2019

Study Completion

September 30, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)