Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572700
Recruitment Status : Unknown
Verified August 2016 by Henning Bliddal, Frederiksberg University Hospital.
Recruitment status was:  Recruiting
First Posted : October 9, 2015
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital

Brief Summary:
The objective of the study is to investigate pain mechanisms, ultrasonographic (US) inflammatory activity and association between these conditions in patients with psoriatic arthritis (PsA) intensifying anti-rheumatic treatment. Further, to assess the predictive value of baseline pain profile and US joint/entheses activity on treatment outcome after 4 months.

Condition or disease Intervention/treatment
Psoriatic Arthritis Other: Pain and US assessment

Detailed Description:

Patients with psoriatic arthritis, who initiate or switch anti-rheumatic treatment (conventional disease modifying drugs or biologic drugs) in routine care due to an active disease state, will be enrolled in the observational study.

The overall aim is to investigate pain mechanisms and US psoriatic changes and elucidate if these factors - independently or by interaction - influence treatment response after 4 months. Patients will have a baseline visit and a follow up visit after 4 months. Examinations will be performed at both time points and include:

  1. Assessment of pain mechanisms by clinical evaluation (swollen/tender joint ratio, tender points) and pain questionnaires (widespread pain index, PainDETECT).
  2. Ultrasonography of joints and entheses by two trained assessors
  3. Clinical examination of all psoriatic manifestations
  4. Interview and questionnaires regarding lifestyle, co-morbidity, function, quality of life and the impact of psoriatic manifestations.
  5. X-ray of hands and feet
  6. Blood samples
  7. AMPS test (assessment of motor and process skills) will be performed and interpreted by an certified ergo therapist.

Clinical as well as patient-reported and observer-based outcomes will be described for the overall study population and the prognostic influence of US- and pain mechanisms will be analysed. Subsequently, the analyses will be repeated for certain subgroups of patients (e.g., conventional drug therapy vs. biologic drug intervention) in an exploratory manner.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Mechanisms and Ultrasonographic Inflammatory Changes as Prognostic Factors in Patients With Psoriatic Arthritis: a Prospective, Exploratory Cohort Study
Study Start Date : September 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with psoriatic arthritis
PsA patients initiating anti-rheumatic treatment in routine care will be included as one group in the observational study. Analyses will be carried out for the overall study population as well as for subgroups (e.g., stratified according to treatment intervention) in an exploratory manner.
Other: Pain and US assessment
All patients will have a baseline visit when treatment is initiated and a follow up visit after 4 months. At each time point, pain mechanisms will be clarified by clinical examination and questionnaires. Besides, ultrasonography of joints and entheses, AMPS test, blood samples, x-ray of hands and feet and interview/additional questionnaires will be applied




Primary Outcome Measures :
  1. American college of rheumatology 20%, [ Time Frame: 4 months from baseline ]
    Composite measures of improvement in disease state (20% improvement)


Secondary Outcome Measures :
  1. American college of rheumatology 50% [ Time Frame: 4 months from baseline ]
    Composite measures of improvement in disease state (50% improvement)

  2. American college of rheumatology 70% [ Time Frame: 4 months from baseline ]
    Composite measures of improvement in disease state (70% improvement)


Other Outcome Measures:
  1. Change in Disease activity 28 Score (DAS28-CRP) [ Time Frame: 4 months from baseline ]
    A composite measure of disease activity

  2. Minimal Disease Activity (MDA) [ Time Frame: 4 months from baseline ]
    A composite measure of disease activity

  3. Change in swollen joint count (SJC) [ Time Frame: 4 months from baseline ]
  4. Change in tender joint count (TJC) [ Time Frame: 4 months from baseline ]
  5. Change in Spondyloarthritis Research Consortium of Canada enthesitis score (SPARCC) [ Time Frame: 4 months from baseline ]
  6. Change in The Psoriatic Arthritis Impact of Disease-score (PsAID) [ Time Frame: 4 months from baseline ]
  7. Change in Dermatology Life Quality Index (DLQI) [ Time Frame: 4 months from baseline ]
  8. Change in Assessment of Motor and Process Skills (AMPS test) [ Time Frame: 4 months from baseline ]
  9. Transition Questionnaire score (Trans-Q) [ Time Frame: 4 months from baseline ]
    Patient's judgement of overall improvement during treatment

  10. Change in PainDETECTquestionnaire score (PDQ) [ Time Frame: 4 months from baseline ]
  11. Change in Health Assessment Questionnaire disability index (HAQ) [ Time Frame: 4 months from baseline ]
  12. Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue [ Time Frame: 4 months from baseline ]
  13. Change in Visual Analogue Scale (VAS) (0-100 mm) of pain [ Time Frame: 4 months from baseline ]
  14. Change in Visual Analogue Scale (VAS) (0-100 mm) of global disease impact [ Time Frame: 4 months from baseline ]
  15. Change in score of Medical Outcomes Study Questionnaire (SF-36) for mental and physical health [ Time Frame: 4 months from baseline ]
  16. Change in psoriasis area severity index (PASI) [ Time Frame: 4 months from baseline ]
  17. Change in ultrasonography joint scores (grey scale and doppler) [ Time Frame: 4 months from baseline ]
  18. Change in ultrasonography entheses scores (grey scale and doppler) [ Time Frame: 4 months from baseline ]
  19. Change in total cholesterol (mmol/L) [ Time Frame: 4 months from baseline ]
  20. Change in body weight (kg) [ Time Frame: 4 months from baseline ]
  21. Change in c-reactive protein (mg/L) [ Time Frame: 4 months from baseline ]
  22. Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: 4 months from baseline ]
  23. Change in Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: 4 months from baseline ]
  24. Withdrawal of treatment due to adverse events during the study period [ Time Frame: 4 months from baseline ]
  25. Withdrawal of treatment due to lack of effect during the study period [ Time Frame: 4 months from baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
> 18 years of age with PsA according to the CASPAR criteria who initiate or switch anti-rheumatic treatment (biologics and/or conventional synthetic DMARDs) due to active PsA in routine care.
Criteria

Inclusion Criteria:

  • Diagnosed with PsA according to the CASPAR (The ClASsification of Psoriatic ARthritis) criteria
  • Peripheral joint involvement.
  • Minimum 18 years of age.
  • Initiating or switching anti-rheumatic treatment due to active PsA.
  • Signing a written informed consent.

Exclusion Criteria:

  • Pregnancy
  • Peripheral neuropathy
  • Demyelinising disease
  • Recent stroke
  • Other rheumatic inflammatory diseases.
  • Oral, intra-articular or intra-muscular glucocorticoids within 3 weeks prior to baseline
  • Treatment with centrally acting analgesics (opioids, anti-depressants, anticonvulsants) within 1 week prior to baseline
  • Treatment with mild analgesics (non-steroidal anti-inflammatory drugs, acetylsalicylic acid, acetaminophen) within 24 hours prior to baseline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572700


Contacts
Layout table for location contacts
Contact: Pil Højgaard, MD 0045 3816 4147 pil.hoejgaard.01@regionh.dk

Locations
Layout table for location information
Denmark
Department of Rheumatology, the Parker Institute, Frederiksberg and Bispebjerg Hospital Recruiting
Frederiksberg, Copenhagen, Denmark, 2000
Contact: Pil Højgaard, MD    0045 38164147    pil.hoejgaard.01@regionh.dk   
Contact: Lars Erik Kristensen, MD, phd       lars.erik.kristensen@regionh.dk   
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
Layout table for investigator information
Study Chair: Lars Erik Kristensen, MD, Ph.D Parker Institute, Frederiksberg Hospital, Frederiksberg, Denmark
Principal Investigator: Henning Bliddal, MD, DMSci the Parker Institute, Frederiksberg Hospital, Frederiksberg, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT02572700    
Other Study ID Numbers: H-15009080
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases