Clinical Characteristics of Importance to Outcome in Patients With Spondyloarthritis

• Conditions: Spondyloarthropathy

• Registration Number: NCT02948608
• Lead Sponsor: Svendborg Hospital

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.

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-28
• Study Start: 2017-03-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07
• Primary Completion: 2019-03-31
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ankylosing Spondylitis Disease Activity Index BASDAI 50 %	≥ 3 month from baseline	composite measures of improvement in disease state (50% improvement)

Secondary Outcome Measures

Name	Time	Method
Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)	≥ 3 month from baseline	composite measures of improvement in disease state

Trial Locations

Locations (1)

Odense University Hospital, Svendborg Hospital; 🇩🇰 Svendborg, Denmark