M31.5
Conditions
Interventions
Group 1: Single-arm follow-up study of patients with giant cell arteritis who have been treated with tocilizumab for at least 1 year, who have been in clinical remission for 6 moants, and who have dis
Sponsors
Universitätsklinikum Erlangen Medizinische Klinik 3
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study must meet all of the following criteria: • Signed informed consent must be obtained prior to participation in the study. • Patients must be able to understand and communicate with the physician and comply with the requirements of the study. • Male or non-pregnant, non-lactating female patients at least 50 years of age. • Classification of GCA according to the modified ACR criteria: o Age at onset of disease = 50 years. o History of ESR = 30 mm/hr and or CRP = 10 mg/L. o Unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication) AND/OR symptoms of polymyalgia rheumatica (PMR) defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness. o Positron emission tomography-computed tomography (PET-CT) revealing features of GCA at time of diagnosis and/or if available at time of diagnosis temporal artery biopsy or other imaging studies like magnetic resonance angiography (MRA), computed tomography angiography (CTA), or ultrasound. • Treatment of GCA with Tocilizumab for at least 52 weeks • Withdrawal of Tocilizumab for clinical reasons (remission) at least 2 weeks/at most 4 weeks prior to screening • Clinical Remission of GCA for at least 6 months prior to Screening o Definition of remission: absence of clinical symptoms for GCA activity during the past 6 months prior to Screening. o Definition of flare: determined by the physician and defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) = 30 mm/hr and or CRP = 10 mg/L attributable to GCA • GCA imaging such as Positron emission tomography-computed tomography (PET-CT), magnetic resonance angiography (MRA), computed tomography angiography (CTA) or ultrasound available from clinical routine performed max. 8 weeks before discontinuation of Tocilizumab prior to screening
Exclusion criteria
Exclusion criteria: Patients who fulfill any of the following criteria are not eligible for inclusion in this study: • Pregnant or lactating women at inclusion • Patients requiring systemic chronic glucocorticoid therapy for any other reason than GCA • Patients requiring chronic high potency opioid analgetics for pain management • Active ongoing inflammatory disease other than GCA that might interfere with the remission definition. • Major ischemic event, unrelated to GCA, within 12 weeks of screening • Major surgery within 8 weeks prior to screening or planned major surgery within 12 months after enrollment. • Inability or unwillingness to undergo repeated venipuncture • Any medical or psychiatric condition which in the physician ’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol. • History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to enrollment. • Have participated in this study before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint Number of patients in clinical remission after 72 weeks clinical monitoring • Definition of remission: absence of flare • Definition of flare: determined by the physician and defined as the recurrence after remission of signs or symptoms of GCA: o Fever (<38°C) o Symtoms of polymyalgia rheumatica (PMR), defined as pain and/or stiffness in the shoulder and/or pelvic girdle. o Headache, scalp or the temporal artery tenderness. o Visual impairment such as acute or subacute vision loss due to anterior ischemic opticus neuropathy (A-AION) or transient blurred vision. o Jaw or mouth pain o claudicatio of the extremities (new or worsened) o other features consistent with GCA or PMR flare evaluated by the clinician. and/or erythrocyte sedimentation rate (ESR) = 30 mm/h and or CRP = 10 mg/L attributable to GCA | — |
Secondary
| Measure | Time frame |
|---|---|
| Further endpoints • Number of patients with flares Definition of flare: determined by the physician and defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) = 30 mm/h and or CRP = 10 mg/L attributable to GCA • Clinical aspects of the flare defined as: o Fever (<38°C) o Symtoms of polymyalgia rheumatica (PMR), defined as pain and/or stiffness in the shoulder and/or pelvic girdle. o Headache, scalp or the temporal artery tenderness. o Visual impairment such as acute or subacute vision loss due to anterior ischemic opticus neuropathy (A-AION) or transient blurred vision. o Jaw or mouth pain o claudicatio of the extremities (new or worsened) o other features consistent with GCA or PMR flare evaluated by the clinician. • Identifying of confounders for GCA patients in remission who do not require Tocilizumab therapy to stay in stable remission • Differences in imaging measurements in patients in remission in comparison to patients with flares (ultrasound, FDG-PET-CT [if available from clinical routine]) • Clinical evaluation, PROs, Laboratory and Composite outcome measures: (BL compared to week 12, week 24, week 48 and week 72) o Flare questionnaire “GCA assessment” (signs and symptoms) o PhGA o ESR o CRP o Cytokines (IL 6, Serum Amyloid A, S100A8/S100A12) o Patient reported outcomes: o PGA o HAQ-DI o SF-36 o FACIT-Fatigue • Additional serum sampling for exploratory biomarker analysis | — |
Countries
Germany
Outcome results
None listed