Tocilizumab Plus a Short Prednisone Taper for GCA
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|ClinicalTrials.gov Identifier: NCT03726749|
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : November 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Giant Cell Arteritis||Drug: Tocilizumab Drug: Prednisone||Phase 4|
This is a single center, open label study that will assess the efficacy and safety of 52 weeks of tocilizumab (TCZ) in combination with 8-weeks of prednisone in 30 patients with active giant cell arteritis (GCA). Active disease is defined as signs and/or symptoms of GCA plus increased inflammatory markers (e.g., erythrosedimentation rate [ESR] and/or C-reactive protein [CRP]).
The study will enroll subjects with new onset and with relapsing/refractory GCA, and consist of a screening phase (up to 6 weeks), a treatment phase (52 weeks) and a safety follow up phase (4 weeks).
The primary endpoint of the study, sustained remission, will be assessed at week 52.
The definition of sustained remission contains 3 elements:
- Absence of clinical signs and symptoms of active GCA along with the normalization of the ESR (< 40 mm/hour) and CRP (< 10 mg/L).
- Completion of the pre-specified prednisone taper protocol
- Absence of disease flare (relapse) since the induction of remission by week 8.
Disease flare is defined as the re-appearance of unequivocal signs or symptoms of active GCA (with or without elevation of ESR and/or CRP) or the elevation of the ESR and/or CRP that is thought to be due to active GCA and that requires escape therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tocilizumab Plus a Short Prednisone Taper for Giant Cell Arteritis (GCA)|
|Actual Study Start Date :||November 28, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||February 2022|
Experimental: Tocilizumab and prednisone
Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor
Other Name: ACTEMRA®
Prednisone is an anti-inflammatory medication
Other Name: Glucocorticoids
- Sustained remission [ Time Frame: 52 weeks ]Proportion of patients in sustained remission by week 52
- Number of disease flares [ Time Frame: 52 Weeks ]Number of disease flares by week 52
- Cumulative prednisone dose [ Time Frame: 52 Weeks ]Cumulative prednisone dose (mg) by week 52
- Adverse events [ Time Frame: 52 weeks ]Number, nature and severity of adverse events by week 52
- Serious adverse events [ Time Frame: 52 weeks ]Number and nature of serious adverse events by week 52
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726749
|Contact: Sebastian H Unizony, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Ana D Fernandes 617-724-2792|
|Principal Investigator: Sebastian Unizony, MD|
|Study Chair:||Ana D Fernandes, MA||Massachusetts General Hospital|