Psoriatic ArthritisGo-ThermalNCT02841176
Thermography in Assessing Treatment Response to Golimumab in Psoriatic Arthritis
A study testing Thermography and Golimumab in people with Psoriatic Arthritis, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Thermography and Golimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to 19 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital
London, W12 0HS
About this study
Official title: A Pilot Study to Evaluate the Utility of Thermography in Assessing Response to Golimumab Treatment in Psoriatic Arthritis
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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Thermography, Golimumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermographyOther
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
GolimumabBiological
Participants will start monthly Golimumab after their baseline visit
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Thermography and Golimumab (solution for subcutaneous injection, 50 or 100 mg, monthly) Receives: Other: Thermography; Biological: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature over arthritic joint surface, measured by thermography
Measured: From baseline up to 97 days
Secondary outcomes (5)
Psoriatic Arthritis Response Criteria (PsARC)
Measured: From baseline up to 97 days
Health Assessment Questionnaire (HAQ-DI)
Measured: From baseline up to 97 days
Psoriasis Area and Severity Index (PASI)
Measured: From baseline up to 97 days
Dermatology Life Quality Index (DLQI)
Measured: From baseline up to 97 days
Visual Analog Scale (VAS) assessment of global health
Measured: From baseline up to 97 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion19 Sep 2017
- Study completion19 Sep 2017
Why it stopped: The study was stopped due to resourcing issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Becky Ward, Study director, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841176
- Sponsor's protocol ID
- 16HH3180
- Acronym
- Go-Thermal
- Status last verified
- Aug 2017
- First submitted
- 16 Jun 2016
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data will be made available within 1 year of the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Utility of Thermography in Assessing Response to Golimumab Treatment in Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT02841176
- Acronym / sponsor ID
- Go-Thermal / 16HH3180
- Conditions
- Psoriatic Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to resourcing issues.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Imperial College London
- Study start
- Jul 2016
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Thermography, Biological: GolimumabThermography and Golimumab (solution for subcutaneous injection, 50 or 100 mg, monthly) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermographyThermographic imaging of arthritic joints will be performed at baseline and within 5 days after the participant's 2nd and 4th doses of monthly Golimumab | Other | Experimental |
| GolimumabParticipants will start monthly Golimumab after their baseline visit | Biological | Experimental |
Primary outcome
Temperature over arthritic joint surface, measured by thermography
Time frame: From baseline up to 97 days
5 secondary outcomes
Psoriatic Arthritis Response Criteria (PsARC)
Time frame: From baseline up to 97 days
Health Assessment Questionnaire (HAQ-DI)
Time frame: From baseline up to 97 days
Psoriasis Area and Severity Index (PASI)
Time frame: From baseline up to 97 days
Dermatology Life Quality Index (DLQI)
Time frame: From baseline up to 97 days
Visual Analog Scale (VAS) assessment of global health
Time frame: From baseline up to 97 days
Results and safety
The study was stopped early (reason given: The study was stopped due to resourcing issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Individual participant dataSharing planned: Yes. De-identified data will be made available within 1 year of the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Becky Ward study director
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermography and Golimumab in people with Psoriatic Arthritis, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to resourcing issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature over arthritic joint surface, measured by thermography (time frame: From baseline up to 97 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.