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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Theraflex, BAY 874017

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1102

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115522
    • Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMS
  • Multiple Locations, Russian Federation
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient who will be made aware about the study either by the treating physician OR by a pharmacist where a patient is purchasing Theraflex

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with Stage I-III Knee osteoarthritis (KOA); Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment	Drug: Theraflex, BAY 874017; 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
Participants with Stage I-III Hip osteoarthritis (HOA); Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment	Drug: Theraflex, BAY 874017; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Pain Intensity Subscale	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.	From enrollment up to 64 weeks
Changes in Other Symptoms Subscale	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.	From enrollment up to 64 weeks
Change in Functional Activity of the Joint Subscale	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.	From enrollment up to 64 weeks
Change in Life Quality Subscale	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.	From enrollment up to 64 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participant Compliance With Drug Utilization of Theraflex	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.	From enrollment up to 64 weeks
Change in Patient Satisfaction Assessment	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	From enrollment up to 64 weeks
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA)	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'.	From enrollment up to 64 weeks
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex	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'.	From enrollment up to 64 weeks

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2017
• Primary Completion (ACTUAL): March 18, 2020
• Study Completion (ACTUAL): July 13, 2020

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (ACTUAL): November 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 19649

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No