Placebo controlled trial to evaluate the effect on pain and function of six months treatment doxycycline in established knee osteoarthritis with an open extension up to two years

Phase 3

Not yet recruiting

• Conditions: OA; osteoarthritis; 10023213

• Registration Number: NL-OMON31361
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

· Knee OA (index knee) according to the 1986 proposed ACR classification tree using clinical and radiological criteria: knee pain (VAS > 40mm during > 50% of last month), the presence of osteophytes and one of the following: age >50, crepitus, or morning stiffness < 30 minutes.
· Kellgren Lawrence score II or III
· Criteria for mild to severe pain (KOOS pain sumscore question 5 to 9 > 100 in the index knee) must be fulfilled
· Ability to read and communicate well in Dutch.

Exclusion Criteria

· Other rheumatic diseases like rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematodes or psoriatic arthritis.
· The presence of secondary OA including OA caused by orthopaedic problems (severe malalignment, trauma), ochronosis, acromegaly, calcium pyrophosphate deposition disease (CPPD), haemochromatosis.
· Severe functional problems related to diseases other than OA (functional class ARA IV)
· Cognitive deficits affecting the scoring processes.
· Severe OA (Kellgren Lawrence score IV)
· Ipsilateral hip prosthesis in situ.
· Contraindications for doxycycline use like allergy for tetracyclines and prior adequate treatment with doxycycline (>100mg for > 6 weeks for OA).
· Planned other major interventions within 24 weeks, including lower limb surgery and intensive multidisciplinary approaches.
· Recent intra-articular hyaluronic acid or corticosteroid application (<3 months) or surgery (<1 year) in the index knee.
· Recent participation in other study (< 3 months)

Study & Design

• Study Type: Interventional
• Study Design: Not specified