1. Knee osteoarthritis (knie artrose)
Conditions
Interventions
The intervention-group will receive 2dd100 mg doxycycline monohydrate during 24 weeks. The control group will receive 2dd placebo during 24 weeks.
Sponsors
Reumacentrum Sint Maartenskliniek Nijmegen
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Knee OA (index knee) according to the 1986 proposed ACR classification tree using clinical and radiological criteria (18): knee pain (VAS > 40mm during > 50% of last month), the presence of osteophytes and one of the following: age >50, crepitus, or morning stiffness 100 in the index knee) must be fulfilled (19); 4. Ability to read and communicate well in Dutch.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Other rheumatic diseases like rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematodes or psoriatic arthritis; 2. The presence of secondary OA including OA caused by orthopaedic problems (severe malalignment, trauma), ochronosis, acromegaly, calcium pyrophosphate deposition disease (CPPD), haemochromatosis; 3. Severe functional problems related to diseases other than OA (functional class ARA IV); 4. Cognitive deficits affecting the scoring processes; 5. Severe OA (Kellgren Lawrence score IV); 6. Ipsilateral hip prosthesis in situ; 7. Contraindications for doxycycline use like allergy for tetracyclines and prior adequate treatment with doxycycline (>100mg for > 6 weeks for OA); 8. Planned other major interventions within 24 weeks, including lower limb surgery and intensive multidisciplinary approaches; 9. Recent intra-articular hyaluronic acid or corticosteroid application (<3 months) or surgery (<1 year) in the index knee; 10. Recent participation in other study (< 3 months); 11. (planned) pregnancy or reproductive state without proper contraceptive method.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Percentage of the patients achieving clinical response on pain and function, as defined by the OMERACT-OARSI set of responder criteria based on the KOOS dutch version - pain (sumscore question 5 to 9) and function sumscore question 1-17 – and VAS patient Global Assessment at week 24 compared between placebo and verum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1. The use of analgesics (mean dose of paracetamol and NSAIDs, normalized for maximal registered dose); 2. Quality of life measured using the SF-36; 3. Safety (adverse events graded according to the CTC criteria). | — |
Contacts
Public ContactA.A. den Broeder
Sint Maartenskliniek
Outcome results
None listed