Clinical trial · Observational
Polymyalgia Rheumatica and Giant Cell Arteritis
Polymyalgia Rheumatica and Giant Cell Arteritis - Three Challenges - Consequences of the Vasculitis Process, Osteoporosis and Malignancy: A Prospective Cohort Study Protocol
NCT02985424CI-TRIAL-00027172unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to delineate the association of the 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT) detected vasculitis pattern of the large vessels (PET positivity) and the clinical picture of Polymyalgia Rheumatica (PMR)/Giant Cell Arteritis (GCA) .
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Giant Cell Arteritis | — | UNRESOLVED | — |
| Polymyalgia Rheumatica | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG PET/CT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Cumulated prednisolone dose within the first year after treatment initiation in patients with and without vasculitis in the large vessels
- timeFrame
- One year
Secondary outcomes (23)
- measure
- Patient reported global visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)
- timeFrame
- One year
- description
- Patient global assessment of disease severity as measured on a visual analogue scale (VAS) that ranges from 0 to 100, in patients with vasculitis in the large vessels detected by PET scan
- measure
- Physician reported visual analogue scale (VAS) in patients with vasculitis in the large vessels (positive PET)
- timeFrame
- One year
- description
- Physician assessment of disease severity as measured on a visual analogue scale (VAS) that ranges from 0 to 100 in patients with vasculitis in the large vessels detected by PET scan.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * At least five (A-E) components of the PMR diagnostic criteria, including: * A. Age ≥50 years, * B. Bilateral shoulder or hip pain, * C. Morning stiffness lasting \>45 min, * D. Elevated erythrocyte sedimentation rate (ESR), * E. Elevated C-reactive protein (CRP), * F. Disease duration \>2weeks, should be met to suspect PMR. * For GCA following criteria's must be seen: Age \> 50 years, ESR/CRP \> 50, as well as at least two symptoms related to vasculitis (scalp tenderness, vision disturbances, headache (new or changed), jaw claudication, tenderness of the temporal arteria) if patients do not simultaneously have PMR. If the patient is suspected for PMR, one cranial symptom is enough to suspect GCA. Exclusion Criteria: * Dementia * Inability to communicate in Danish * Infections or malignancy when prednisolone is permanently unsuitable * Contraindication to imaging studies (allergy to contrast materials, reduced kidney function, pregnancy and Blood Sugar (BS) \>8 mmol/l after 6 hours fasting) * Initiation of steroid treatment before the PET scan * Inability to provide informed consent
References
Publications (1)
- DERIVEDEmamifar A, Hess S, Ellingsen T, Gerke O, Ahangarani Farahani Z, Syrak Hansen P, Jensen Hansen IM, Thye-Ronn P. Clinical presentation and treatment response in patients with polymyalgia rheumatica and giant cell arteritis during a 40-week follow-up. Rheumatol Adv Pract. 2021 Nov 24;5(3):rkab091. doi: 10.1093/rap/rkab091. eCollection 2021. PMID 34909566