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The study was stopped due to resourcing issues.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Imperial College London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Thermography and Golimumab (solution for subcutaneous injection, 50 or 100 mg, monthly) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Temperature over arthritic joint surface, measured by thermography | From baseline up to 97 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Becky Ward | Imperial College Healthcare NHS Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital | London | W12 0HS | United Kingdom |
De-identified data will be made available within 1 year of the end of the study
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D013817 | Thermography |
| C529000 | golimumab |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D062125 | Thermometry |
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| Golimumab | Biological | Participants will start monthly Golimumab after their baseline visit |
|
| 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 |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008919 |
| Investigative Techniques |