Clinical trial NCT02948608: Clinical Characteristics of Importance to Outcome in Patients With Spondyloarthritis
Official title: Effectiveness and Patient-reported Outcomes in Patients With Spondyloarthropathies Treated With Biological Agents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spondyloarthropathy
Keywords: spondyloarthropathy
ankylosing spondylitis
spinal diseases
spondylitis
spondylarthritis
psoriasis
uveitis
joint diseases
Lead sponsor: Svendborg Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Parker Research Institute
name: Spine Centre of Southern Denmark
First posted: 2016-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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.

Detailed description: Patients with spondyloarthropaty, who initiate or switch biologics in routine care due to an active disease state, will be enrolled in this observational study.

The overall aim is to investigate extra-articular manifestations, pain mechanisms and patient-reported outcomes and elucidate if these factors - independently or by interaction - influence treatment response after ≥ 3 months. Patients will have a baseline visit, an eye examination and a follow up visit after ≥ 3 months. Clinical examinations will be performed at both time points and include:

1. Clinical examination (the spinal movement)
2. Assessment of pain mechanisms by clinical evaluation (BASDAI, tender points,) and pain questionnaires (PainDETECT).
3. The SPARCC Enthesitis Index will be used to enthesitis count.
4. Interview and questionnaires regarding lifestyle, comorbidity, function and quality of life
5. Blood samples
6. Urine samples
7. Stool samples

Clinical as well as patient-reported and observer-based outcomes will be described for the overall study population and the prognostic influence of extra-articular manifestations, comorbidity and pain mechanisms will be analysed.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Ankylosing Spondylitis Disease Activity Index BASDAI 50 %
timeFrame: ≥ 3 month from baseline
Secondary outcomes:
measure: Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: ≥ 3 month from baseline
Other outcomes:
measure: To analyse the influence of PDQ score on the treatment response
timeFrame: ≥ 3 month from baseline
measure: Characterisation of the extra-articular manifestations in SpA patients
timeFrame: at baseline and ≥ 3 months from baseline
measure: Change in Bath Akylosing Spondylitis Functional Index (BASFI)
timeFrame: ≥ 3 month from timeline
measure: Change in Spondylitis Consortium of Canada enthesitis score (SPARCC)
timeFrame: ≥ 3 month from baseline
measure: Change in score of Medical Outcomes Study Questionnaire (SF-36) for mental and physical Health
timeFrame: ≥ 3 month from baseline
measure: Change in plasma calprotectin (microg/L)
timeFrame: ≥ 3 month from baseline
measure: Change in the Simple Clinical Colitis Activity Index (SCCAI)
timeFrame: ≥ 3 month from baseline
measure: Change in the Harvey Bradshaws Activity Index (HBAI)
timeFrame: ≥ 3 month from baseline
measure: Change in fecal calprotectin (mg/kg)
timeFrame: ≥ 3 month from baseline
measure: Change in C-Reactive Protein, CRP (mg/L)
timeFrame: ≥ 3 month from baseline
measure: Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue
timeFrame: ≥ 3 month from baseline
measure: Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue of pain
timeFrame: ≥ 3 month from baseline
measure: Change in Visual Analogue Scale (VAS) (0-100 mm) of global disease impact
timeFrame: ≥ 3 month from baseline
measure: Withdrawal of treatment due to adverse event during the study period
timeFrame: ≥ 3 month from baseline
Locations:
city: Svendborg
country: Denmark
facility: Odense University Hospital, Svendborg Hospital
Study officials:
affiliation: Svendborg Hospital
name: Inger Marie J Hansen, MD, DmSci
role: STUDY_CHAIR
References:
citation: 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.