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Thermography in Assessing Treatment Response to Golimumab in Psoriatic Arthritis (Go-Thermal)

Primary Purpose

Psoriatic Arthritis

Status

Terminated

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Thermography

Golimumab

About this trial

This is an interventional other trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), active tuberculosis infection, viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess. Less serious infections need not be considered exclusions at the discretion of the investigator.
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

Sites / Locations

NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

Temperature over arthritic joint surface, measured by thermography

Secondary Outcome Measures

Psoriatic Arthritis Response Criteria (PsARC)

Health Assessment Questionnaire (HAQ-DI)

Psoriasis Area and Severity Index (PASI)

Dermatology Life Quality Index (DLQI)

Visual Analog Scale (VAS) assessment of global health

Full Information

NCT ID

NCT02841176

First Posted

June 16, 2016

Last Updated

March 20, 2019

Sponsor

Imperial College Healthcare NHS Trust

Collaborators

Merck Sharp & Dohme LLC, Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT02841176

Brief Title

Thermography in Assessing Treatment Response to Golimumab in Psoriatic Arthritis

Acronym

Go-Thermal

Official Title

A Pilot Study to Evaluate the Utility of Thermography in Assessing Response to Golimumab Treatment in Psoriatic Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Why Stopped

The study was stopped due to resourcing issues.

Study Start Date

July 2016 (undefined)

Primary Completion Date

September 19, 2017 (Actual)

Study Completion Date

September 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College Healthcare NHS Trust

Collaborators

Merck Sharp & Dohme LLC, Imperial College London

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Psoriatic Arthritis is a joint problem (arthritis) that often occurs with a skin condition called psoriasis. Psoriasis is a common skin problem that causes red patches on the body, and it is an on-going (chronic) inflammatory condition. About 1 in 20 people with psoriasis will develop arthritis with the skin condition. In most cases, psoriasis comes before the arthritis. The cause of Psoriatic Arthritis is not known. Psoriatic Arthritis can be treated using different types of drugs to reduce pain and swelling of the joints. New medicines that block an inflammatory protein called tumor necrosis factor (TNF) are being widely used for progressive Psoriatic Arthritis, as is the case of the drug Golimumab. Thermography is the use of images to study heat distribution in different parts of the body, and allows one to see variations in temperature, for example in detecting joint inflammation. This is a pilot study to evaluate whether thermography is able to reliably detect joint inflammation in Psoriatic Arthritis, and whether it is able to detect improvement or worsening in inflammation during medical treatment with Golimumab. This involves assessing disease activity using some questionnaires, examining of patient joints, performing blood tests, ultrasound and thermography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Thermography

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Golimumab

Intervention Description

Participants will start monthly Golimumab after their baseline visit

Primary Outcome Measure Information:

Title

Temperature over arthritic joint surface, measured by thermography

Time Frame

From baseline up to 97 days

Secondary Outcome Measure Information:

Title

Psoriatic Arthritis Response Criteria (PsARC)

Time Frame

From baseline up to 97 days

Title

Health Assessment Questionnaire (HAQ-DI)

Time Frame

From baseline up to 97 days

Title

Psoriasis Area and Severity Index (PASI)

Time Frame

From baseline up to 97 days

Title

Dermatology Life Quality Index (DLQI)

Time Frame

From baseline up to 97 days

Title

Visual Analog Scale (VAS) assessment of global health

Time Frame

From baseline up to 97 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), active tuberculosis infection, viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess. Less serious infections need not be considered exclusions at the discretion of the investigator. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Becky Ward

Organizational Affiliation

Imperial College Healthcare NHS Trust

Official's Role

Study Director

Facility Information:

Facility Name

NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital

City

London

ZIP/Postal Code

W12 0HS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified data will be made available within 1 year of the end of the study

Learn more about this trial

Thermography in Assessing Treatment Response to Golimumab in Psoriatic Arthritis

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