Requirements Human Subjects
Human subjects protection requirements
Subject Requirements
Key Population Characteristics
- Adults aged 40–80 years
- Clinical diagnosis of knee or hip osteoarthritis
- Symptoms present for at least 6 months
- Radiographic evidence consistent with osteoarthritis
- Moderate to severe pain involving the designated index joint
- Functional limitation associated with the index joint
- Able to understand and complete electronic patient-reported outcome assessments
- Able to participate in voice-enabled assessments
- Willing to comply with study visits and protocol requirements
Inclusion Criteria
Participants must:
- Be 40–80 years of age
- Provide informed consent
- Have a clinical diagnosis of osteoarthritis of the knee or hip
- Have symptoms involving the index joint for at least 6 months
- Have radiographic evidence consistent with osteoarthritis
- Have moderate to severe index-joint pain at screening and baseline
- Demonstrate functional limitation associated with the index joint
- Be able to complete electronic assessments in the study language
- Be capable of participating in conversational voice assessments
- Be willing to comply with study procedures
- Maintain protocol-permitted background therapies as required
Exclusion Criteria
Participants will be excluded for:
- Inflammatory arthritis, including rheumatoid arthritis
- Significant joint disease other than osteoarthritis affecting interpretation of study outcomes
- Recent major surgery involving the index joint
- Planned knee or hip replacement during the study
- Recent intra-articular therapy within the protocol-defined washout period
- Serious uncontrolled medical illness
- Active infection affecting study participation
- Current participation in another interventional clinical trial
- Any condition that, in the investigator's judgment, could interfere with reliable assessment or participant safety