Erosive osteoarthritis of the hand (EHOA) MedDRA version: 14.1 Level: LLT Classification code 10019115 Term: Hand osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Apremilast
Product Code: CC-10004
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: CC-10004
Other descriptive name: NA
Con
Sponsors
Med. Fakultaet der Friedrich-Alexander Universitaet Erlangen-Nuernberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Must understand and voluntarily sign an informed consent form including written consent for data protection - Must be male or female and aged = 18 years at time of consent - Must have a diagnosis of erosive hand osteoarthritis according to ACR criteria for at least six months - Must have at least two bone erosions detectable in conventional radiographs of the hands at the first carpo-metacarpal joint (CMC), proximal and/or distal interphalangeal joints - Must have active disease at screening and randomization with at least two swollen and tender PIP and/or DIP joints; with the same two joints affected at both screening and randomization. - Must have a patients self assessment of pain at baseline of at least 40% on a VAS - Must have negative rheumatoid factor (RF) and anti-CCPantibody 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of any clinically significant inflammatory disease other than EHOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies - History or Diagnosis of Fibromyalgia - Any injury, medical or surgical procedure to the affected joint(s) that may interfere with evaluation of the target hand OA joint(s) - Pregnant or lactating female - History of active Mycobacterium tuberculosis infection within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated - Any anti-inflammatory or immunosuppressive therapy for any condition including, but not limited to, glucocorticoids, methotrexate, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, parenteral corticosteroids, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus and azathioprine within 35 days of randomization and throughout the study - Use of NSAIDs within 35 days of randomization and throughout the study - Have a known history of serious infections (eg, hepatitis, pneumonia, or pyelonephritis) in the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the 84-day efficacy of apremilast 20 mg twice per day [BID], subsequent to a 7-day dose titration, compared with placebo, for the treatment of the symptoms of erosive hand osteoarthritis.;Secondary Objective: Further objectives are to evaluate the effects on pain, disease activity, structural damage, quality of life, safety and tolerability.;Primary end point(s): Proportion of subjects in each treatment group who achieve a significant 50% improvement in AUSCAN Index at day 84 after treatment start compared with baseline.;Timepoint(s) of evaluation of this end point: Day 84 after treatment start | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Absolute values and change from baseline as well as proportion of patients in each treatment group who achieve improvements (=0%, =20%, =50%) in the following self reporting tests, at day 84 and at day 168 after treatment start compared with Baseline: AUSCAN index, Patients self assessment of pain (VAS), Physicians and Patients self assessment of global status (VAS), HAQ, SACRAH, Duration of joint stiffness, Swollen and tender joint counts, RAMRIS scoring system, SF36, Safety and Tolerability.;Timepoint(s) of evaluation of this end point: Day 84 and Day 168 after treatment start | — |
Countries
Germany
Contacts
Public ContactDepartment of Internal Medicine 3
Med. Fakultaet der Friedrich-Alexander Universitaet Erlangen-Nuernberg
Outcome results
None listed