Nexia Remote Subject Monitoring

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