Thermography in Assessing Treatment Response to Golimumab in Psoriatic Arthritis

NCT02841176 | Terminated

• 1 other identifier: 16HH3180
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be an open label pilot study to explore the utility of thermography in assessing response to Golimumab treatment in Psoriatic Arthritis (PsA). Ten patients fulfilling the Classification criteria for Psoriatic Arthritis (CASPAR) for Psoriatic Arthritis with active disease and eligible for anti-TNF therapy will be invited to participate in this study. They will be assessed at 4 time points during the study: prior to their first anti-TNF medication (screening and basal visits), and subsequently within 5 days after their 2nd and 4th doses of monthly Golimumab.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Temperature over arthritic joint surface, measured by thermography

  From baseline up to 97 days

Secondary Outcomes (5)

• Psoriatic Arthritis Response Criteria (PsARC)

  From baseline up to 97 days

• Health Assessment Questionnaire (HAQ-DI)

  From baseline up to 97 days

• Psoriasis Area and Severity Index (PASI)

  From baseline up to 97 days

• Dermatology Life Quality Index (DLQI)

  From baseline up to 97 days

• Visual Analog Scale (VAS) assessment of global health

  From baseline up to 97 days

Study Arms (1)

Experimental

EXPERIMENTAL

Thermography and Golimumab (solution for subcutaneous injection, 50 or 100 mg, monthly)

Other: Thermography; Biological: Golimumab

Interventions

Thermography OTHER

Thermographic imaging of arthritic joints will be performed at baseline and within 5 days after the participant's 2nd and 4th doses of monthly Golimumab

Experimental

Golimumab BIOLOGICAL

Participants will start monthly Golimumab after their baseline visit

Experimental

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 to 95 years
• Patients fulfilling the CASPAR criteria for Psoriatic Arthritis with active disease
• Subjects eligible for anti-TNF therapy (ie. have 3 or more swollen and 3 or more tender joints who have failed treatment with 2 disease modifying drugs) and planning to be treated with Golimumab.
• Subjects may be on oral steroids (prednisone ≤10 mg/day, or equivalent corticosteroid) with a stable dose for the 4 weeks prior to Week 0.
• Subjects may be on oral NSAIDs with a stable dose for the 4 weeks prior to Week 0.
• Subjects must be able to adhere to the study visit schedule.
• The subjects must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.

You may not qualify if:

• Known HIV, Hepatitis B, or Hepatitis C infection.
• Known hypersensitivity to Golimumab (active substance or to any of the excipients).
• Allergic reactions (bronchospasm, hypersensitivity, urticaria).
• Patients who have undergone surgical procedures, including arthroplasty, within the previous year.
• Latex sensitivity (The needle cover on the prefilled Golimumab pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex).
• Temperature \>38.3°C
• Gastrointestinal inflammatory disorders
• Asthma and related symptoms (such as wheezing and bronchial hyperactivity)
• Malignancy within the past 5 years (such as skin cancer, squamous cell carcinoma and melanocytic naevus)
• Known recent substance abuse (drug or alcohol).
• Planning to have surgery for PsA or other significant surgery during the period of the study.
• Participation in another clinical trial involving receipt of an investigational product in the 30 days preceding enrolment, or planned during the study period
• Unable to undergo any of the study procedures

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• Merck Sharp & Dohme LLC: collaborator
• Imperial College London: collaborator

Study Sites (1)

NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Thermography; golimumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Thermometry; Investigative Techniques

Study Officials

• Becky Ward

  Imperial College Healthcare NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: July 22, 2016
• Study Start: July 1, 2016
• Primary Completion: September 19, 2017
• Study Completion: September 19, 2017
• Last Updated: March 22, 2019

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)