Placebo controlled trial to evaluate the effect on pain and function of six months treatment doxycycline in established knee osteoarthritis - Doxy in Knee OA

Conditions: Osteoarthritis of the knee, mild to severe pain
MedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritis

Registration Number: EUCTR2007-001151-19-NL

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 230

Inclusion Criteria

·Knee OA (index knee) according to the 1986 proposed ACR classification tree using clinical and radiological criteria (17): 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To asses the short term effect on pain and function and the safety of doxycycline in patients with mild to severe pain due to established knee OA.;Secondary Objective: ;Primary end point(s): 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 (19) - 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 Outcome Measures