Clinical Characteristics of Importance to Outcome in Patients With Spondyloarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02948608
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Svendborg Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Inger Marie J Hansen, MD, DmSci
Principal Investigator Affiliation Svendborg Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spondyloarthropathy
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Svendborg, Denmark

Status

Recruiting

Address

Odense University Hospital, Svendborg Hospital

Svendborg, , 5700

Site Contact

Rikke A Andreasen, MD

Rikke.asmussen@rsyd.dk

+45 63202506

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