Clinical Characteristics of Importance to Outcome in Patients With Spondyloarthritis

Spondyloarthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02948608
• Other study ID #: S-20160094
• Secondary ID: R-144-A4136
• Status: Active, not recruiting
• Start date: March 1, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2019
• Source: Svendborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylarthropathies
• Spondyloarthropathy

Locations

Country	Name	City	State
Denmark	Odense University Hospital, Svendborg Hospital	Svendborg

Sponsors (4)

Lead Sponsor	Collaborator
Svendborg Hospital	Odense University Hospital, Parker Research Institute, Spine Centre of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Change in Bath Akylosing Spondylitis Functional Index (BASFI)		= 3 month from timeline
Other	Change in Spondylitis Consortium of Canada enthesitis score (SPARCC)		= 3 month from baseline
Other	Change in score of Medical Outcomes Study Questionnaire (SF-36) for mental and physical Health		= 3 month from baseline
Other	Change in plasma calprotectin (microg/L)		= 3 month from baseline
Other	Change in the Simple Clinical Colitis Activity Index (SCCAI)	composite measures of improvement in disease state	= 3 month from baseline
Other	Change in the Harvey Bradshaws Activity Index (HBAI)	composite measures of improvement in disease state (Crohns disease)	= 3 month from baseline
Other	Change in fecal calprotectin (mg/kg)		= 3 month from baseline
Other	Change in C-Reactive Protein, CRP (mg/L)		= 3 month from baseline
Other	Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue		= 3 month from baseline
Other	Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue of pain		= 3 month from baseline
Other	Change in Visual Analogue Scale (VAS) (0-100 mm) of global disease impact		= 3 month from baseline
Other	Withdrawal of treatment due to adverse event during the study period		= 3 month from baseline
Primary	Ankylosing Spondylitis Disease Activity Index BASDAI 50 %	composite measures of improvement in disease state (50% improvement)	= 3 month from baseline
Secondary	Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)	composite measures of improvement in disease state	= 3 month from baseline