This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
932
Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52
Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI.
Time frame: Baseline, Week 52
Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee
A "structural progressor" was defined as a participant who had an 8% cartilage loss in cMTFC. Number of participants who met the criteria of "structural progressor" at Week 52 are provided.
Time frame: Week 52
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score and Subscales Scores for Pain, Function, and Stiffness to Week 52
Western Ontario and McMaster Universities Osteoarthritis Index is a questionnaire designed to assess health status and health outcomes in participants with OA of the knee. The questionnaire contains 24 questions targeting areas of pain, stiffness, and physical function. Pain subscale includes 5 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-20 with higher scores indicating worse symptoms and function. Stiffness subscale includes 2 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-8 with higher scores indicating worse symptoms and function. Physical function subscale includes 17 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-68 with higher scores indicating worse symptoms and function. The total score is the sum of all subscales (range: 0 to 96) with higher scores indicating worse symptoms and function.
Time frame: Baseline, Week 52
Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52
The participant was asked "how would you rate the pain felt in the selected knee within the last 48 hours?". The participants rated the pain by marking the level of pain on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher pain intensity.
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Central Research Associates, Inc.
Birmingham, Alabama, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Hope Research Institute, LLC - Arizona
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Clinical Research Consortium Arizona
Tempe, Arizona, United States
Samy Metyas MD, Inc - Covina Arthritis Clinic
Covina, California, United States
TriWest Research Associates, LLC
El Cajon, California, United States
BioSolutions Clinical Research Center
La Mesa, California, United States
The Helm Center for Pain Management
Laguna Hills, California, United States
...and 34 more locations
Time frame: Baseline, Week 52
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52
The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated the disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.
Time frame: Baseline, Week 52
Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria
OMERACT-OARSI criteria involves improvement based on WOMAC pain and function subscales and PGA. The responders according to OMERACT-OARSI criteria were participants who had: * A high improvement in pain or in function ≥ 50% and absolute change ≥ 20, OR * Improvement in at least 2 of the 3 following: * Pain ≥ 20% and absolute change ≥ 10 * Function ≥ 20% and absolute change ≥ 10 * Patient's global assessment ≥ 20% and absolute change ≥ 10. WOMAC pain subscale score: range of 0 to 20, higher scores indicating more pain, WOMAC physical function subscale score: range of 0 to 68, higher scores indicating worse physical function), PGA: The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.
Time frame: Week 52
Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52
Reduction of cartilage loss was measured by cartilage thickness of the tTFC of the target knee using qMRI.
Time frame: Baseline, Week 52
Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28
Time frame: Baseline, Week 28
Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52
Time frame: Baseline, Week 52
Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52
The JSW is the space measured between the 2 bones in the knee joint and this is assessed by x-ray.
Time frame: Baseline, Week 52
Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study
Systemic analgesics included anti-inflammatory and anti-rheumatic products; analgesics; anti-diarrheals, intestinal, anti-inflammatory/anti-infective agents; and drugs for functional gastrointestinal disorders.
Time frame: Baseline up to Week 52
Plasma Concentrations of GLPG1972
Time frame: Pre-dose at Weeks 4, 12, and 52; Pre-dose and one post-dose sample (2-4 hours interval) at Week 28; one post dose sample (interval 4-8 hours) at Week 40
Number of Participants With Treatment-emergent Adverse Event (TEAE)
TEAEs were defined as all adverse events (AEs) that occurred: * between first IMP intake date (included) and last visit of participant, or * before first IMP intake date and that worsened (in terms of intensity) or became serious according to investigator opinion between first IMP intake date (included) and last visit of participant. Number of participants with at least 1 TEAE (serious or non-serious) are reported.
Time frame: Baseline up to 2-weeks after last dose of IMP (up to Week 54)