A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain
- Conditions
- Osteoarthritis, Knee
- Interventions
- Registration Number
- NCT02192190
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain. The study drugs will be given as an injection under the skin and as an oral capsule. The study will last about 28 weeks for each participant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 268
- Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria and confirmed with X-rays and ACR functional class of I to III
- Have been on stable dose of prescription Nonsteroidal Anti-Inflammatory Drugs (NSAIDS), celecoxib, tramadol, or acetaminophen of at least 2000 mg per day for at least 20 days in the past month
- Willing to stop all analgesics for OA pain during the study
- Experienced pain while walking in the target knee of 50-90 mm inclusive on 0-100 Visual Analog Scale (VAS) with an increase in pain while walking of at least 10 mm following washout of current Osteoarthritis pain medications at screening
- Allergic to LY2951742, celecoxib, other NSAIDS, including aspirin, and similar drugs
- Arthritis of the knee from other causes
- Uncontrolled hypertension
- Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intra-articular injections, duloxetine, or venlafaxine
- Moderate to severe renal impairment
- Pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo- oral Placebo capsule orally, once daily for approximately 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks (Treatment period = 16 weeks). Placebo Placebo - SC Placebo capsule orally, once daily for approximately 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks (Treatment period = 16 weeks). Celecoxib + Placebo Placebo - SC Celecoxib 200 milligram (mg) capsule orally once daily for approximately 16 weeks. Placebo SC once every 4 weeks for 16 weeks (Treatment period = 16 weeks). LY2951742 5 mg + Placebo LY2951742 Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 5 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 5 mg + Placebo Placebo- oral Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 5 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 5 mg + Placebo Placebo - SC Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 5 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 50 mg + Placebo Placebo- oral Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 50 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 50 mg + Placebo Placebo - SC Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 50 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 120 mg + Placebo LY2951742 Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 120 mg + Placebo Placebo- oral Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 120 mg + Placebo Placebo - SC Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 300 mg + Placebo LY2951742 Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 300 mg + Placebo Placebo- oral Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 300 mg + Placebo Placebo - SC Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). LY2951742 50 mg + Placebo LY2951742 Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 50 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). Celecoxib + Placebo Celecoxib Celecoxib 200 milligram (mg) capsule orally once daily for approximately 16 weeks. Placebo SC once every 4 weeks for 16 weeks (Treatment period = 16 weeks).
- Primary Outcome Measures
Name Time Method Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Baseline, 8 Weeks The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter \[mm\] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.
- Secondary Outcome Measures
Name Time Method Number of Participants With a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI) 8 Weeks The responders according to OMERACT-OARSI criteria: participants with at least 50 % improvement in pain or in function scores, along with absolute improvement of 20 mm, were considered responders. Alternatively, participants were considered responders if they showed at least 20% improvement and absolute improvement of 10 mm in at least two of the following scores: pain, function and Patients Global Assessment (PGA) scores.
Change From Baseline to 8 Weeks in the WOMAC Total Score Baseline, 8 Weeks The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales.The WOMAC total score was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 24 questions. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale Baseline, 8 Weeks The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC physical function subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of all 17 questions related to physical function. Least Square Mean (LSM) was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis Baseline, 8 Weeks The PGA is a patient-rated instrument that measures their assessment of overall OA symptoms. It is based on the participant's response to the question "Considering all the ways your osteoarthritis affects you, how are you doing today?" using a 100 mm VAS (0=very good and 100=very poor). LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale Baseline, 8 Weeks The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC stiffness subscale will be calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 2 questions related to stiffness. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Trial Locations
- Locations (37)
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Empire Clinical Research
🇺🇸Upland, California, United States
Medex Healthcare Research, Inc.
🇺🇸New York, New York, United States
Dream Team Clinical Research
🇺🇸Anaheim, California, United States
Research Institute of South Florida, Inc.
🇺🇸Miami, Florida, United States
M&M Medical Center
🇺🇸Miami, Florida, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Arthritis, Rheumatic & Back Disease Associates
🇺🇸Voorhees, New Jersey, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Accurate Clinical Research
🇺🇸Nassau Bay, Texas, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Horizons Clinical Research Center
🇺🇸Denver, Colorado, United States
Avail Clinical Research LLC
🇺🇸DeLand, Florida, United States
Community Research Foundation Inc
🇺🇸Miami, Florida, United States
United Osteoporosis Center
🇺🇸Gainesville, Georgia, United States
Compass Research
🇺🇸Orlando, Florida, United States
Buynak Clinical Research, P.C.
🇺🇸Valparaiso, Indiana, United States
ActivMed Practices & Research, Inc
🇺🇸Methuen, Massachusetts, United States
The Center for Clinical Trials, Inc.
🇺🇸Biloxi, Mississippi, United States
New Mexico Clinical Research & Osteoporosis Center
🇺🇸Albuquerque, New Mexico, United States
Family Practice Center of Wooster
🇺🇸Wooster, Ohio, United States
Drug Trials of America
🇺🇸Hartsdale, New York, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Greater Providence Clinical Research, LLC
🇺🇸Warwick, Rhode Island, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Quality Research, Inc.
🇺🇸San Antonio, Texas, United States
Health Research of Hampton Roads Inc
🇺🇸Newport News, Virginia, United States
National Clinical Research - Norfolk Inc
🇺🇸Norfolk, Virginia, United States
Clinical Research Associates of Tidewater
🇺🇸Norfolk, Virginia, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
iM Research
🇺🇸West Covina, California, United States
PCPMG Clinical Research Unit
🇺🇸Greenville, South Carolina, United States
Upstate Clinical Research Associates
🇺🇸Williamsville, New York, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States