N/A
N=1,102
Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex Treatment
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03330288 ↗Enrolled (actual)
1,102
Serious AEs
1.3%
Results posted
Oct 2021
Primary outcome: Primary: Changes in the Pain Intensity Subscale — 18.07; 15.59; 20.92; 20.06 Scores on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Theraflex, BAY 874017 (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Pain Intensity Subscale |
18.07; 15.59; 20.92; 20.06; 22.87; 22.81 | — |
| PRIMARY Changes in Other Symptoms Subscale |
15.48; 12.65; 18.87; 17.10; 20.78; 19.93 | — |
| PRIMARY Change in Functional Activity of the Joint Subscale |
10.98; 13.26; 14.26; 16.41; 16.60; 18.77 | — |
| PRIMARY Change in Life Quality Subscale |
16.29; 14.25; 20.79; 18.82; 24.87; 22.71 | — |
| SECONDARY Number of Participant Compliance With Drug Utilization of Theraflex |
753; 253; 59; 21; 12; 4 | — |
| SECONDARY Change in Patient Satisfaction Assessment |
0.8; 0.8; 0.8; 0.9; 0.9; 0.9 | — |
| SECONDARY Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) |
274; 103; 84; 25; 36; 4 | — |
| SECONDARY Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex |
20; 5; 11; 6; 9; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03330288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.