Clinical Trial: Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Colchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety
Brief Summary:
Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a very frequent affection of the elderly and causes very painful arthritis.
International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.
The treatment of CPPD arthritis is extrapolated from the experience of gout treatment, another crystal deposition disease.
Among recommended treatments, colchicine and oral steroids are recommended as first-line treatments, while NSAIDs are used with caution in elderly populations of patients.
Colchicine utilization is not risk-free, in particular with old patients and patients with renal impairment.
Drug interactions of colchicine can have serious consequences, especially in a polymedicated old patient's population.
Oral steroids are an interesting alternative in this indication with a potential of being better tolerated, but comparative efficacy with colchicine needs to be studied.
From a broader point of view, colchicine and oral steroids have never been compared in any crystal related arthritis.
This is the first large randomized controlled trial for CPPD acute arthritis.
Detailed Summary:
Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a very frequent affection of the elderly and causes very painful arthritis.
International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.
Some factors are known to trigger CPPD arthritis (trauma, surgery, infection, hospitalization). Prevalence increases with age, and case series estimate the presence of chondrocalcinosis in over 20% of 80 plus years population.
International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.
The treatment of CPPD arthritis is extrapolated from the experience of gout treatment, another crystal deposition disease (this one related to monosodium urate crystals that deposit after long-standing hyperuricemia.
Among recommended treatments, colchicine and oral steroids are recommended as first-line treatments, while NSAIDs are used with caution in elderly populations of patients.
Colchicine utilization is not risk-free, in particular with old patients and patients with renal impairment. Drug interactions of colchicine can have serious consequences, especially in a polymedicated old patient's population. Oral steroids offer an interesting alternative with the potential of being better tolerated.
However, even oral steroids are recommended, their efficacy in CPPD arthritis isn't demonstrated. Interesting comparative results
Sponsor: Lille Catholic University
Current Primary Outcome: Change from baseline in the pain VAS at 24 hours [ Time Frame: From the first treatment administration to 24 hours after. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of patients with at least one adverse event within 48 hours [ Time Frame: 48 hours following the first administration ]Proportion of patients with at least one adverse event within 48 hours following the first drug intake (diarrhea, abdominal pain, nausea, vomiting, a 50% fasting blood glucose increase, excitability, sleep disorders, high blood pressure apparition [above 140/90mmHg], change in creatinine clearance)
- Change from baseline of biological inflammatory syndrome at 48 hours [ Time Frame: From the first treatment administration to 48 hours after. ]C Reactive Protein change from baseline 48 hours after the first treatment intake.
- Number of joints affected and their localizations [ Time Frame: Before, 24 hours and 48 hours after the first administration ]Number of affected articulations and their localization before the first intake, after 24 hours and after 48 hours.
- Need of emergency morphinic treatment [ Time Frame: 24 hours after the first administration ]Proportion of patients requiring analgesia with morphine within the first 24 hours.
- Analgesic consumption [ Time Frame: From 24 hours to 48 hours after the first treatment administration ]Proportion of patients requiring additional analgesics between the 24th and 48th hour following the 1st intake.
- Proportion of patients with an efficacy response of at least 50% [ Time Frame: 24 hours and 48 hours after the first administration. ]Proportion of patients with at least a 50% decrease in pain VAS at 24 and 48 hours after the first intake.
- Proportion of patients with an efficacy response of at least 20% [ Time Frame: 8, 12 and 24 hours after the first administration. ]Proportion of patients with at least a 20% decrease in pain VAS at 8, 12 and 24 hours after the first administration.
- Complete crisis resolution within 7 days [ Time Frame: 7 days after 1st administration ]Proportion of patient with a complete resolution of the arthritis within the 7 days after 1st intake (defined by a ≤3/10 VAS score)
- Initial crisis resolution delay [ Time Frame: 7 days after 1st administration ]Delay to the complete resolution of the arthritis from the first drug intake
- Absence of crisis recidivism within 7 days [ Time Frame: Within the 7 days following the 1st administration ]Relapse rate within the 7 days following the 1st intake (defined by the recurrence of pain with a >3/10 VAS score)
Original Secondary Outcome: Same as current
Information By: Lille Catholic University
Dates:
Date Received: April 6, 2017
Date Started: September 2017
Date Completion: February 2019
Last Updated: April 21, 2017
Last Verified: April 2017
