Clinical Characteristics of Importance to Outcome in Patients With Spondyloarthritis

Effectiveness and Patient-reported Outcomes in Patients With Spondyloarthropathies Treated With Biological Agents

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.

Study Overview

• Status: Unknown
• Conditions: Spondyloarthropathy

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Denmark
  • Svendborg, Denmark, 5700
    • Odense University Hospital, Svendborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankylosing Spondylitis Disease Activity Index BASDAI 50 %	composite measures of improvement in disease state (50% improvement)	≥ 3 month from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)	composite measures of improvement in disease state	≥ 3 month from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To analyse the influence of PDQ score on the treatment response	we analyse if the painDETECT questionnaire score (PDQ) at baseline can influence on treatment outcome	≥ 3 month from baseline
Characterisation of the extra-articular manifestations in SpA patients	To characterise the extra-articular manifestations according to ASAS criteria	at baseline and ≥ 3 months from baseline
Change in Bath Akylosing Spondylitis Functional Index (BASFI)		≥ 3 month from timeline
Change in Spondylitis Consortium of Canada enthesitis score (SPARCC)		≥ 3 month from baseline
Change in score of Medical Outcomes Study Questionnaire (SF-36) for mental and physical Health		≥ 3 month from baseline
Change in plasma calprotectin (microg/L)		≥ 3 month from baseline
Change in the Simple Clinical Colitis Activity Index (SCCAI)	composite measures of improvement in disease state	≥ 3 month from baseline
Change in the Harvey Bradshaws Activity Index (HBAI)	composite measures of improvement in disease state (Crohns disease)	≥ 3 month from baseline
Change in fecal calprotectin (mg/kg)		≥ 3 month from baseline
Change in C-Reactive Protein, CRP (mg/L)		≥ 3 month from baseline
Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue		≥ 3 month from baseline
Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue of pain		≥ 3 month from baseline
Change in Visual Analogue Scale (VAS) (0-100 mm) of global disease impact		≥ 3 month from baseline
Withdrawal of treatment due to adverse event during the study period		≥ 3 month from baseline

Collaborators and Investigators

• Sponsor: Svendborg Hospital
• Collaborators: Odense University Hospital; Parker Research Institute; Spine Centre of Southern Denmark
• Investigators: Study Chair: Inger Marie J Hansen, MD, DmSci, Svendborg Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): March 31, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 28, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: psoriasis; ankylosing spondylitis; uveitis; spondyloarthropathy; spinal diseases; spondylitis; spondylarthritis; joint diseases
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis; Spondylarthropathies
• Other Study ID Numbers: S-20160094; R-144-A4136 (Other Grant/Funding Number: The Danish Rheumatism Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No