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

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Theraflex, BAY 874017

• Registration Number: NCT03330288
• Lead Sponsor: Bayer

Brief Summary

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-10-06
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Study Start: 2017-11-20
• Primary Completion: 2020-03-18
• Study Completion: 2020-07-13
• Results First Submitted: 2021-06-16
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-17
• Last Update Submitted: 2021-09-17
• Results First Posted: 2021-10-14
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1102

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in the Pain Intensity Subscale	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.
Changes in Other Symptoms Subscale	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.
Change in Functional Activity of the Joint Subscale	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.
Change in Life Quality Subscale	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 Outcome Measures

Name	Time	Method
Number of Participant Compliance With Drug Utilization of Theraflex	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.
Change in Patient Satisfaction Assessment	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
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA)	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'.
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex	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'.

Trial Locations

Locations (2)

Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMS; 🇷🇺 Moscow, Russian Federation

Many locations; 🇷🇺 Multiple Locations, Russian Federation