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Completed

NCT Number: NCT03330288

Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex Treatment

The main purpose of this study is to evaluate how a long-term treatment with Theraflex during 64 weeks affects pain intensity in the affected knee or hip joint, the activity in daily living, the quality of life and patient satisfaction with treatment.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMS, Moscow, Russia

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About this study

Other information that is planned for evaluation in this study includes consumption of Theraflex, intake of analgesics for joint pain relief and description of basic patient characteristics such as age, weight and body mass index and others.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 45 to 75 years with Hip or Knee OA stage I to III
  • Patient started current treatment with Theraflex not more than 2 weeks prior to inclusion into the study
  • Personally signed and dated informed consent

Exclusion criteria

  • Patients participating in an investigational program with interventions outside of routine clinical practice
  • Patients with Hip or Knee OA stage 0 or stage IV
  • Patients who have both Hip and Knee OA and OA of any other location
  • Contraindications for use of Theraflex in accordance with approved label(known hypersensitivity, severe chronic renal failure)
  • Females who are pregnant or breastfeeding
  • Patients who completed a treatment with Theraflex or another combination of Gl+ Ch less than 5 months before start of the current treatment
  • Patients who completed intra-articular corticosteroids treatment in the last 3 months to exclusion criteria
  • Patients who completed hyaluronic injections of the lower limbs in the last 6 months

Treatment and study plan

Theraflex, BAY 874017

Drug

The first three weeks which do have a different posology (3 capsules a day) according to the label should be entered as a distinct period to the treatment period with a recommended posology of 2 capsules a day

Primary outcomes

  1. Changes in the Pain Intensity Subscale

    Time frame: From enrollment up to 64 weeks

    KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Pain intensity is one subscale of KOOS and HOOS questionnaire, each pain intensity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS pain intensity subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS pain intensity subscale results calculation used a similar method.

  2. Changes in Other Symptoms Subscale

    Time frame: From enrollment up to 64 weeks

    KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Other symptoms is one subscale of KOOS and HOOS questionnaire, each other symptoms question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS other symptoms subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS other symptoms subscale results calculation used a similar method.

  3. Change in Functional Activity of the Joint Subscale

    Time frame: From enrollment up to 64 weeks

    KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Functional activity is one subscale of KOOS and HOOS questionnaire, each functional activity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS functional activity subscale were calculated by converting value of all subscale questions to KOOS-Physical Short form score. Results score is from 0 to 100, 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS functional activity subscale results used a similar method with HOOS-Physical Short form.

  4. Change in Life Quality Subscale

    Time frame: From enrollment up to 64 weeks

    KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Life quality is one subscale of KOOS and HOOS questionnaire, each life quality question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS life quality subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS life quality subscale results calculation used a similar method.

Secondary outcomes

  1. Number of Participant Compliance With Drug Utilization of Theraflex

    Time frame: From enrollment up to 64 weeks

    Drug utilization of Theraflex as reported by the patient to their physician. Administration duration categories are: 1.patients receiving Theraflex up to 1 month inclusive; 2.patients taking Theraflex during 1 to 3 months; 3.patients taking Theraflex during 3 to 6 months; 4. patients taking Theraflex during more than 6 months. Investigators assessed compliance with the recommendations for the duration of Theraflex.

  2. Change in Patient Satisfaction Assessment

    Time frame: From enrollment up to 64 weeks

    Patient satisfaction questionnaire was filled out during the visit to a doctor. A patient assessed treatment satisfaction against the Likert response scale : 5-very satisfied, 4-Satisfied, 3- No answer, 2-Dissatisfied, 1-very dissatisfied

  3. Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA)

    Time frame: From enrollment up to 64 weeks

    Concomitant therapy of the target joint osteoarthritis (OA) by choosing any of the following categories: 'Symptomatic therapy with analgesics for the target joint OA', 'Other drug treatment for pain syndrome of the target joint OA', 'Other therapy for the target joint OA'.

  4. Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex

    Time frame: From enrollment up to 64 weeks

    Concomitant therapy of the target joint osteoarthritis (OA) by choosing any of the following categories: 'Symptomatic therapy with analgesics for the target joint OA', 'Other drug treatment for pain syndrome of the target joint OA', 'Other therapy for the target joint OA'.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex® Treatment to Evaluate Changes in Pain, Functions in Daily Living, and Quality of Life for an Observation Period up to 64 Weeks

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2017
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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