A study to investigate the safety and effectiveness of different doses of a new drug (sprifermin- also called AS902330) in patients with osteoarthritis of the knee
- Conditions
- Primary osteoarthritisMedDRA version: 16.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-003059-20-PL
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 545
The trial will enroll adult subjects of either sex with primary femorotibial osteoarthritis according to American College of Rheumatology (ACR) clinical and radiographic criteria who have Kellgren-Lawrence grades of 2 or 3 and a minimum joint space width (JSW) of = 2.5 mm in the medial compartment.
Subjects must have pain in the target knee on most days and/or require symptomatic treatment of knee pain with paracetamol (acetaminophen), systemic non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 selective inhibitor (coxibs), or tramadol on most days of the previous month, and must have both:
* A history of pain due to OA in the target knee for at least 6 months, and
* Pain score for the target knee of 4 to 9 points in response to Question 1 of the WOMAC pain index(how much pain have you had [in the target knee, over the past 48 hours] when walking on a flat
surface?”) at screening and baseline, after washout of at least 5-half-lives of analgesic medication(s): acetaminophen, topical or oral systemic NSAIDS, coxibs, opioids, and/or tramadol.
Women of childbearing potential must use a form of contraception with a failure rate of less than 1% per year throughout the trial.
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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 275
Main exclusion criteria are malalignment of > 5 degrees in the femorotibial axis of the target knee, clinical signs of inflammation (i.e., redness) in the target knee, i.a. administration of corticosteroids or hyaluronic acid into either knee within 6 months before screening, any plan for knee surgery (affecting either the target or the contralateral knee) within the next two years, concomitant conditions or treatments deemed to be incompatible with trial participation, contraindications to MRI scanning (including inability to fit in the scanner or knee coil), pregnancy or breastfeeding, participation in another clinical trial within the past 30 days, and legal incapacity or limited legal capacity.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method