Giant Cell Arteritis MedDRA version: 23.1 Level: PT Classification code 10018250 Term: Giant cell arteritis System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: Guselkumab
Product Code: CNTO1959
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GUSELKUMAB
Current Sponsor code: CNTO 1959
Other descriptive name: GUSELKUMAB
Concentra
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. At least 50 years of age, inclusive 3. Diagnosis of GCA according to the revised American College of Rheumatology criteria 4. Temporal artery biopsy revealing features of GCA either at time of diagnosis or at other timepoint during disease history OR, Evidence of cranial GCA either at time of diagnosis or at other timepoint during disease history by doppler-ultrasound, cranial Magnetic Resonance Imaging or Magnetic Resonance Angiography, or other imaging modality upon agreement with the sponsor OR Evidence of GCA by angiography or cross-sectional imaging (ultrasound, MRI, CT, PET). 5. Have new onset or relapsing GCA 6. Have active GCA within 6 weeks of first study intervention Please see section 5.1 in the protocol for all inclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 41
Exclusion criteria
Exclusion criteria: 1. Has any known severe or uncontrolled GCA complications 2. Has any rheumatic disease other than GCA such as Takayasu's Arteritis, granulomatosis with polyangiitis (Wegener's), RA, systemic lupus erythematosus that could interfere with assessment of GCA 3. Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances 4.1a. Has or has had any major ischemic event, within 12 weeks of first study intervention 4.1b. Has a personal history of arterial thrombosis or venous thromboembolism (including deep venous thrombosis [DVT] and Pulmonary Embolism [PE]) 5. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of indetermined significance; or signs and symptoms sug. Has or has had any major ischemic event, within 12 weeks of firstgestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly 19. Has had a fracture of the hip or leg, major trauma or spinal cord injury, hip or knee replacement within 8 weeks before screening; had major surgery within 8 weeks before screening, or has not fully recovered from such major surgery, or has such major surgery planned during the time the participant is expected to participate in the study (48 weeks) 23. Has started Methotrexate (MTX) within 12 weeks of first study intervention. If started MTX >12 weeks prior to first study intervention MTX must have been at a stable dose for minimally 4 weeks and must not be receiving more than 25 mg oral or SC MTX per week Please see section 5.2 in the protocol for all exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA);Secondary Objective: - To evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week GC taper regimen, in adult participants with new-onset or relapsing GCA as measured by alternative definitions of GC free remission, GC-sparing effects, and prevention of disease flares. - To evaluate the safety of guselkumab, in combination with a 26-week GC taper regimen, in adult participants with new-onset or relapsing GCA. - To evaluate the PK and immunogenicity of guselkumab, in combination with a 26-week GC taper regimen, in adult participants with new-onset or relapsing GCA. ;Primary end point(s): The proportion of participants achieving GC-free remission;Timepoint(s) of evaluation of this end point: Week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The proportion of participants achieving GC-free remission from Week 28 by visit through Week 52 - The proportion of participants achieving GC-free remission and normalization of erythrocyte sedimentation rate (ESR) at Week 28 and by visit through Week 52 - The proportion of participants achieving GC-free remission and normalization of C-reactive protein (CRP) at Week 28 and by visit through Week 52 - The proportion of participants achieving GC-free remission and normalization of both ESR and CRP at Week 28 and by visit through Week 52 - The cumulative GC dose through Week 28 and through Week 52 - The time to first GCA disease flare or discontinuation of study intervention due to AE of worsening of GCA through Week 28 and through Week 52 - The number of GCA disease flares or discontinuation of study intervention due to AE of worsening of GCA through Week 28 and through Week 52 - Number/proportion of participants with TEAEs by system organ class with a frequency threshold of 5% or more through Week 60 - Number/proportion of participants with treatment-emergent serious adverse events (SAEs) through Week 60 - Number/proportion of participants with clinically significant abnormalities in vital signs, laboratory safety tests through Week 60 - Mean (standard deviation [SD]) serum concentrations of guselkumab through Week 52 in participants receiving active study intervention. - Number/proportion of participants with antibodies to guselkumab in participants receiving active study intervention.;Timepoint(s) of evaluation of this end point: Week 28, 52 and 60 | — |
Countries
Belgium, Canada, France, Germany, Israel, Italy, Poland, Spain, United States
Contacts
Public ContactClinical Registry group
Janssen Biologics B.V.
Outcome results
None listed