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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03330288

Enrollment

1102

Registered

2017-11-06

Start date

2017-11-20

Completion date

2020-07-13

Last updated

2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DRUGTheraflex, 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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'.

Countries

Russia

Participant flow

Recruitment details

Study was conducted at 51 centers in Russian Federation, between 20-Nov-2017 (first participant first visit) and 13-Jul-2020 (Database clean). The Primary Completion date is 18-Mar-2020 (last participant last visit)

Pre-assignment details

A total of 1111 participants were screened over the course of the study, of which 1102 participants were enrolled in the study. Among them, 824 participants were diagnosed with knee osteoarthritis (KOA), while 278 participants were diagnosed with hip osteoarthritis (HOA).

Participants by arm

Arm	Count
Participants With Stage I-III Knee Osteoarthritis (KOA) Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment	824
Participants With Stage I-III Hip Osteoarthritis (HOA) Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment	278
Total	1,102

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	0
Overall Study	Lost to Follow-up	26	7
Overall Study	Other reason	1	1
Overall Study	Switching to a different disease-modifying delayed-release drug SYSADOA	1	0
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Participants With Stage I-III Hip Osteoarthritis (HOA)	Total	Participants With Stage I-III Knee Osteoarthritis (KOA)
Age, Continuous	60.3 Years STANDARD_DEVIATION 7.21	60.4 Years STANDARD_DEVIATION 6.97	60.4 Years STANDARD_DEVIATION 6.9
Functional activity of the joint subscale	65.57 Scores on a scale STANDARD_DEVIATION 16.515	NA Scores on a scale	61.46 Scores on a scale STANDARD_DEVIATION 10.599
Life quality subscale	46.79 Scores on a scale STANDARD_DEVIATION 17.507	NA Scores on a scale	44.99 Scores on a scale STANDARD_DEVIATION 17.009
Other symptom subscale	61.17 Scores on a scale STANDARD_DEVIATION 17.691	NA Scores on a scale	62.25 Scores on a scale STANDARD_DEVIATION 18.034
Pain intensity subscale	60.97 Scores on a scale STANDARD_DEVIATION 17.321	NA Scores on a scale	61.48 Scores on a scale STANDARD_DEVIATION 16.434
Patient satisfaction assessment	3.1 Scores on a scale STANDARD_DEVIATION 0.42	3.1 Scores on a scale STANDARD_DEVIATION 0.48	3.2 Scores on a scale STANDARD_DEVIATION 0.5
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	3 Participants	3 Participants
Race (NIH/OMB) Black or African American	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	278 Participants	1098 Participants	820 Participants
Sex: Female, Male Female	240 Participants	968 Participants	728 Participants
Sex: Female, Male Male	38 Participants	134 Participants	96 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 278	1 / 824
other Total, other adverse events	28 / 278	55 / 824
serious Total, serious adverse events	6 / 278	8 / 824

Outcome results

Primary

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.