Active Axial Spondyloarthritis (SpA) MedDRA version: 14.1 Level: LLT Classification code 10041672 Term: Spondylitis ankylosing System Organ Class: 100000004859
Conditions
Interventions
Trade Name: SIMPONI
Product Name: SIMPONI
Product Code: MK-8259 / SCH 900259
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Co
Sponsors
Schering-Plough Research Institute, a Division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Each subject must be =18 to =45 years of age. 2. Each subject must have a physician’s diagnosis of active axial SpA with disease duration =5 years, and chronic back pain of =3 month duration. 3. Each subject must meet either criterion “a” or “b” as adopted from ASAS classification criteria: a. Active inflammation on MRI highly suggestive of sacroiliitis associated with spondyloarthropathy (as evidenced by the central reader) and 1 or more of the following spondyloarthritis characteristics OR b. HLA-B27+ gene and 2 or more of the following spondylarthritis characteristics (not including HLA-B27): ? Inflammatory back pain, defined as having at least 4 out of the 5 following parameters: ? age at onset upper limit of normal based on central lab values); ? HLA-B27+ gene; 4. Each subject must show high disease activity at Screening and Baseline of both a total back pain evaluation of =40 mm on a VAS of 0-100 mm and a BASDAI score of = 40 mm. 5. Each subject must have either an inadequate response (as assessed by the investigator) to 30 days of continuous therapy with maximal recommended daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a maximal dose of NSAID therapy for a full 30 days because of intolerance, toxicity, or contraindications to NSAIDs. 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 225 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional X-rays (ie, excluding modified New York criteria) based on central reading at Screening. 2. The subject has ever received TNF-a targeted therapy or any biological agents, including but not limited to infliximab, etanercept, adalimumab, alefacept or efalizumab, rituximab, or natalizumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of golimumab50 mg compared to placebo in the treatment of active axial SpA, as measured by proportion of subjects achieving Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16 and to demonstrate the safety and tolerability of golimumab 50 mg through Week 16 in the active axial SpA population.;Secondary Objective: To evaluate the treatment effect of golimumab 50 mg compared to placebo as measured by the proportion of subjects achieving ASAS 40 response at Week 16. To evaluate the treatment effect of golimumab 50 mg compared to placebo, as measured by the proportion of subjects who achieve Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response at Week 16. To evaluate the treatment effect of golimumab 50 mg compared to placebo, as measured by the proportion of subjects who achieve ASAS partial remission at Week 16. To evaluate the treatment effect of golimumab 50 mg compared to placebo by the change in the Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) joints scoring from Baseline to Week 16. ;Primary end point(s): The primary efficacy endpoint for the trial is the proportion of subjects meeting the ASAS 20 response at Week 16.;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Key Secondary Efficacy Endpoints are: • Proportion of subjects meeting the ASAS 40 response at Week 16; • Proportion of subjects achieving BASDAI 50 at Week 16; • Proportion of subjects in ASAS partial remission at Week 16; • Change in SPARCC MRI SI joints scoring from Baseline to Week 16. ;Timepoint(s) of evaluation of this end point: Week 16 | — |
Countries
Canada, Czech Republic, Denmark, Finland, Germany, Greece, Ireland, Italy, Norway, Russian Federation, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Project Manager
Merck Sharp & Dohme Corp., a subsidiary of Merck& Co., Inc., USA
Outcome results
None listed