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The combination of prednisone and colchicine in patients with primary sclerosing cholangitis - Head-to-head comparisons of medication uses, side effects, ratings, and more.
Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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.
Some factors are known to trigger CPPD arthritis trauma, surgery, infection, hospitalization. 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.
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. These results may not be fully extrapolated to CPPD which holds differences with gout. In addition, oral steroids were not compared to colchicine which is the benchmark treatment in many countries for CPPD.
The aim of this study is to compare the efficacy of colchicine and oral steroids for the treatment of CPPD acute arthritis and compare their tolerance profile. It is the first large randomized controlled trial comparing two treatments of CPPD acute arthritis. All involved know the identity of the intervention assignment.
Drug: Colchicine opocalcium 1mg International non-proprietary name: Colchicine. Active principle : Crystallized colchicine Excipients: Erythrosine aluminium lake, lactose, saccharose, magnesium stearate and povidone. Active principle : Prednisone Excipients: Maize starch, lactose, talc, magnesium stearate. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
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Read our disclaimer for details. Last Update Posted : October 13, See Contacts and Locations. View this study on Beta. Study Description. Detailed Description:. Drug Information available for: Prednisone Colchicine. FDA Resources. Arms and Interventions. Composition : Active principle : Crystallized colchicine Excipients: Erythrosine aluminium lake, lactose, saccharose, magnesium stearate and povidone.
Patients assigned to this group will receive Prednisone : Cortancyl 20mg. Composition : Active principle : Prednisone Excipients: Maize starch, lactose, talc, magnesium stearate.
Outcome Measures. C Reactive Protein change from baseline 48 hours after the first treatment intake. Number of affected articulations and their localization before the first intake, after 24 hours and after 48 hours. Proportion of patients requiring analgesia with morphine within the first 24 hours. Proportion of patients requiring additional analgesics between the 24th and 48th hour following the 1st intake. Delay to the complete resolution of the arthritis from the first drug intake.
Eligibility Criteria. By the existence of a typical clinical arthritis joint pain, erythema, swelling, maximal intensity in less than 24h AND presence of chondrocalcinosis signs in knee, wrists, or pubic symphysis on plain X-rays or crowned tooth in cervical rachis scan. Signed patient's consent. Affiliation to a social security scheme. Patient under guardianship, curatorship Patient receiving morphinic analgesia.
Gout history or presence of monosodium urate crystals at the examination of the synovial fluid. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. National Library of Medicine U.
National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Drug: Colchicine opocalcium 1mg Drug: Prednisone : Cortancyl 20mg.
Phase 3. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. No masking is used. Actual Study Start Date :.
Estimated Primary Completion Date :. Estimated Study Completion Date :. Active Comparator: Colchicine Patients assigned to this group will receive the Colchicine opocalcium 1mg treatment.
Other Name: Mayoly-Spindler laboratory. Experimental: Prednisone corticoids Patients assigned to this group will receive Prednisone : Cortancyl 20mg. Other Name: Sanofi Aventis France. April 25, Key Record Dates.
❿Prednisone and colchicine.Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis (COLCHICORT)
Colcrys colchicine is a second-choice treatment for gout attacks. Be careful how much you use since it can cause problems with your blood. Deltasone prednisone is effective for controlling allergic reactions and conditions involving an overactive immune system. It can quickly make you feel better, but Deltasone prednisone can cause serious complications and side effects if taken for a long time. Compare Colcrys vs. Colcrys colchicine Prescription only. Deltasone prednisone Prescription only.
Prevents and treats gout. Calms down your immune system. Colcrys colchicine treats and stops sudden gout attacks. It can be used to prevent gout when people are first starting on allopurinol. Colcrys colchicine also treats Familial Mediterranean fever. Deltasone prednisone effectively treats a variety of conditions involving the immune system. Can help improve energy and stimulate your appetite. Works quickly to provide relief for swelling, rash, asthma attacks, and pain.
Good long-term treatment option for autoimmune disorders. Deltasone prednisone is available in a generic form. Colcrys colchicine doesn't work as well as nonsteroidal anti-inflammatory drugs NSAIDs or corticosteroids to treat gout attacks. Taking Colcrys colchicine for too long can cause problems with your blood. Doses needs to be changed if you have kidney or liver problems. While Colcrys colchicine stops the redness and swelling of gout attacks, it doesn't stop the pain.
If you're taking Colcrys colchicine to stop gout flare-ups, you can only use it for 3 to 6 months after your levels have stabilized. The capsules Mitigare are only approved for prevention, but not treatment of gout.
Deltasone prednisone can cause unwanted side effects such as mood changes, trouble sleeping, and increase in blood pressure as well as blood sugar at higher doses. Long-term use can cause problems to your skin, bones, eyes, and place you at a higher risk for infections. If Deltasone prednisone is used for more than 2 weeks, you will need to work with a doctor to taper off the medicine by gradually decreasing the dose. Deltasone prednisone can harm an unborn baby, so it's not a good option for pregnant women.
Learn more. Not enough review data. Leave a review. Blood disorders. Physicial Dependence. Learn more about Colcrys colchicine Learn more about Deltasone prednisone.
❾-50%}Be careful how much you use since it can cause problems with your blood. Deltasone prednisone is effective for controlling allergic reactions and conditions involving an overactive immune system. It can quickly make you feel better, but Deltasone prednisone can cause serious complications and side effects if taken for a long time. Compare Colcrys vs. Colcrys colchicine Prescription only. Deltasone prednisone Prescription only. Prevents and treats gout. Calms down your immune system. Colcrys colchicine treats and stops sudden gout attacks.
It can be used to prevent gout when people are first starting on allopurinol. Colcrys colchicine also treats Familial Mediterranean fever. Arms and Interventions. Composition : Active principle : Crystallized colchicine Excipients: Erythrosine aluminium lake, lactose, saccharose, magnesium stearate and povidone.
Patients assigned to this group will receive Prednisone : Cortancyl 20mg. Composition : Active principle : Prednisone Excipients: Maize starch, lactose, talc, magnesium stearate. Outcome Measures. C Reactive Protein change from baseline 48 hours after the first treatment intake. Number of affected articulations and their localization before the first intake, after 24 hours and after 48 hours.
Proportion of patients requiring analgesia with morphine within the first 24 hours. Proportion of patients requiring additional analgesics between the 24th and 48th hour following the 1st intake. Delay to the complete resolution of the arthritis from the first drug intake. Eligibility Criteria. By the existence of a typical clinical arthritis joint pain, erythema, swelling, maximal intensity in less than 24h AND presence of chondrocalcinosis signs in knee, wrists, or pubic symphysis on plain X-rays or crowned tooth in cervical rachis scan.
Signed patient's consent. Affiliation to a social security scheme. Patient under guardianship, curatorship Patient receiving morphinic analgesia. Gout history or presence of monosodium urate crystals at the examination of the synovial fluid. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.
More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Drug: Colchicine opocalcium 1mg Drug: Prednisone : Cortancyl 20mg.
Phase 3. Study Type :. Their course was compared with that of a group of concurrent historical controls. At 6 and 12 months, there was significantly more improvement in liver test results over baseline values in patients receiving prednisone and colchicine than in the untreated controls.
At 24 months, however, no significant differences in biochemical tests were appreciated between treated and untreated patients. Analysis of serial liver biopsies showed no differences in histologic change in the two groups. During the 2 yr of follow-up, there were two deaths in the control group but none in the treated group.
Primary sclerosing cholangitis is a cholestatic liver disease characterized by inflammation and fibrosis of the biliary tract. The cause of the disease is unknown, and no effective medical treatment exists.
Their course was compared with that of a group of concurrent historical controls. At 6 and 12 months, there was significantly more improvement in liver test results over baseline values in patients receiving prednisone and colchicine than in the untreated controls. At 24 months, however, no significant differences in biochemical tests were appreciated between treated and untreated patients. Analysis of serial liver biopsies showed no differences in histologic change in the two groups.
During the 2 yr of follow-up, there were two deaths in the control group but none in the treated group. Four untreated patients developed ascites; gastrointestinal bleeding developed in three untreated patients, one of whom developed ascites. In contrast, in the treated group, ascites and bleeding developed in only one patient.
We conclude that the combination of colchicine and prednisone does not retard histologic progression or progression of standard liver tests after 2 yr of therapy.
There is a trend toward less clinical deterioration and improved survival after 2 yr of treatment. On the basis of these findings, we would not advocate empiric use of these drugs for patients with primary sclerosing cholangitis, but suggest that, if they are to be used at all in PSC, they be evaluated in a controlled clinical trial as treatment for this as yet incurable disease.
Abstract Primary sclerosing cholangitis is a cholestatic liver disease characterized by inflammation and fibrosis of the biliary tract. Publication types Clinical Trial Comparative Study. Substances Colchicine Prednisone.
We conclude that the combination of colchicine and prednisone does not retard histologic progression or progression of standard liver tests after 2 yr of. Low dose prednisolone and colchicine were both effective in treating RAS. Given that the two therapies had similar efficacy, yet colchicine. We conclude that the combination of colchicine and prednisone does not retard histologic progression or progression of standard liver tests after 2 yr of. Colchicine is indicated for the treatment and prevention of gout flares. toxicity with NSAIDs or prednisone, eg diabetes, or peptic. Colcrys (colchicine) is a second-choice treatment for gout attacks. Be careful how much you use since it can cause problems with your blood. Colcrys colchicine doesn't work as well as nonsteroidal anti-inflammatory drugs NSAIDs or corticosteroids to treat gout attacks. Compare Colcrys vs. April 25, Key Record Dates. Drug: Colchicine opocalcium 1mg Drug: Prednisone : Cortancyl 20mg. Study Description.Nulla at venenatis eros. Lying efficitur, orci ut cursus consectetur, nisi elit convallis odio, non hendrerit arcu tortor aliquet eros. Nullam imperdiet diam ut neque ullamcorper semper. Mauris consequat ex sed elit venenatis, eu varius nulla posuere.
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