Behcet's SyndromePhase 2NCT00700297
Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease
A Phase 2 study testing Colchicine in people with Behcet's Syndrome, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Colchicine was first used in Behcet's Disease (BD), in 1977. There are controversial reports of the efficacy of Colchicine in BD. For some experts the unresponsiveness of some patients could be explained by genetic difference between the Silk Road BD and sporadic BD from other parts of the world. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Behcet's Syndrome
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 1 siteIran
- Study dates
- Aug 2002to May 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient's who fulfilled the International Criteria for Behcet's Disease.
Who cannot join
- major organ involvement
- Hypersensitivity reaction
Trial locations and contacts
1 site in 1 country.
Iran1 site
Rheumatology research Center, Tehran UMS
Tehran, Tehran Province, 14114
About this study
Official title: A Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet's Disease
Colchicine was first used in Behcet's Disease (BD), in 1977. There are controversial reports of the efficacy of Colchicine in BD. For some experts the unresponsiveness of some patients could be explained by genetic difference between the Silk Road BD and sporadic BD from other parts of the world.
To test this hypothesis (the inefficacy of colchicine in the Silk Road BD), we designed a randomized double-blind controlled crossover study in Iran, which is in the middle of the Silk Road, and has the second highest prevalence of BD in the world.
Read the detailed description
Patients: They were selected as consecutive patients.
The entry criteria was: age between 14 and 60 years, confirmed diagnosis of Behcet's Disease, absence of major organ involvement (eye, brain, lung, and cardio-vascular involvement), having at least one active symptom, and no treatment for at least one month. Patients were explained the study design and they gave a signed written consent. During the two phases of study, if a major organ involvement appeared, the patient was moved out of the study. All patients fulfilled the new International Criteria for Behcet's Disease.
Method: patients were randomized at the study entry to take either colchicine or placebo. At 4 months, they were crossed over. Those who were taking colchicine went on placebo and those on placebo went on colchicine. Each patient tried therefore, both colchicine and placebo. The primary outcome was the effect of colchicine on the disease activity index, the IBDDAM (16-17). To calculate the overall IBDDAM of the baseline, the IBDDAM of the last 12 months (prior to the study) of each manifestation was calculated and added together. The overall disease activity index was then divided to the number of months (12 months) to have the mean activity index per month. IBDDAM was then measured every 2 months (in the middle and at the end, in each arm of the study). The total IBBDAM of the 4 months was then divided by 4 to have the mean activity index per month. The secondary outcome was to see how the individual symptoms responded to colchicine (IBDDAM of each manifestation).
Statistical analysis: The analysis was done by the intention to treat method. As the difference between IBDDAM before and after treatment had normal distribution Student T test for paired samples were used to evaluate the outcome in the colchicine and the placebo group. As the Levene's test showed the homogeneity of variance, ANOVA (one way) was used to test the effect of treatment (colchicine and placebo) and gender on patients' outcome. The dependent variable was the difference between IBDDAM (before and after the treatment). The independent variables were the treatment, and the gender. SPSS 15 was used for all statistical calculations.
- Conditions
- Behcet's Syndrome
- Being tested
- Colchicine, Placebo
- Keywords
- Oral aphthosis, Genital aphthosis, Psuedofolliculitis, Erythem nodusom, Joint manifestations, Colchicine
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Modacine
100 mg Colchicine per day for 4 months
PlaceboDrug
One tablet placebo per day for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | Patients who received Colchicine and went on placebo after 4 months Receives: Drug: Colchicine |
| Placebo | Placebo comparator | Patients who received placebo and went on Colchicine after 4 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM)
Measured: 8 months
Secondary outcomes (5)
Oral Aphthosis
Measured: 8 months
Genital Aphthosis
Measured: 8 months
Psuedofolliculitis
Measured: 8 months
Erythem Nodusom
Measured: 8 months
Joint Manifestations
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startAug 2002
- Primary completionOct 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Behcet's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Fereydoun Davatchi, Professor, Study chair, Rheumatology Research Center, Tehran University for Medical SciencesBahar Sadeghi, MD, Principal investigator, Rheumatology research Center, Tehran University for Medical SciencesArash Tehrani Banihashemi, MD, MPH, Principal investigator, Rheumatology Research Center, Tehran University for Mrdical SciencesFarhad Shahram, Professor, Principal investigator, Rheumatology Research Center, Tehran University for Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700297
- Sponsor's protocol ID
- rrc-23
- Status last verified
- May 2008
- First submitted
- 17 Jun 2008
- Last updated
- 18 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Davatchi F, Shams H, Rezaipoor M, Sadeghi-Abdollahi B, Shahram F, Nadji A, Chams-Davatchi C, Akhlaghi M, Faezi T, Naderi N. Rituximab in intractable ocular lesions of Behcet's disease; randomized single-blind control study (pilot study). Int J Rheum Dis. 2010 Aug;13(3):246-52. doi: 10.1111/j.1756-185X.2010.01546.x.
PubMed 20704622Davatchi F, Sadeghi Abdollahi B, Tehrani Banihashemi A, Shahram F, Nadji A, Shams H, Chams-Davatchi C. Colchicine versus placebo in Behcet's disease: randomized, double-blind, controlled crossover trial. Mod Rheumatol. 2009;19(5):542-9. doi: 10.1007/s10165-009-0200-2. Epub 2009 Jul 14.
PubMed 19597921
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet's Disease
- ClinicalTrials.gov ID
- NCT00700297
- Acronym / sponsor ID
- rrc-23
- Conditions
- Behcet's Syndrome
- Keywords
- Oral aphthosis, Genital aphthosis, Psuedofolliculitis, Erythem nodusom, Joint manifestations, Colchicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Oct 2005 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colchicine was first used in Behcet's Disease (BD), in 1977. There are controversial reports of the efficacy of Colchicine in BD. For some experts the unresponsiveness of some patients could be explained by genetic difference between the Silk Road BD and sporadic BD from other parts of the world.
To test this hypothesis (the inefficacy of colchicine in the Silk Road BD), we designed a randomized double-blind controlled crossover study in Iran, which is in the middle of the Silk Road, and has the second highest prevalence of BD in the world.
Detailed description
Patients: They were selected as consecutive patients.
The entry criteria was: age between 14 and 60 years, confirmed diagnosis of Behcet's Disease, absence of major organ involvement (eye, brain, lung, and cardio-vascular involvement), having at least one active symptom, and no treatment for at least one month. Patients were explained the study design and they gave a signed written consent. During the two phases of study, if a major organ involvement appeared, the patient was moved out of the study. All patients fulfilled the new International Criteria for Behcet's Disease.
Method: patients were randomized at the study entry to take either colchicine or placebo. At 4 months, they were crossed over. Those who were taking colchicine went on placebo and those on placebo went on colchicine. Each patient tried therefore, both colchicine and placebo. The primary outcome was the effect of colchicine on the disease activity index, the IBDDAM (16-17). To calculate the overall IBDDAM of the baseline, the IBDDAM of the last 12 months (prior to the study) of each manifestation was calculated and added together. The overall disease activity index was then divided to the number of months (12 months) to have the mean activity index per month. IBDDAM was then measured every 2 months (in the middle and at the end, in each arm of the study). The total IBBDAM of the 4 months was then divided by 4 to have the mean activity index per month. The secondary outcome was to see how the individual symptoms responded to colchicine (IBDDAM of each manifestation).
Statistical analysis: The analysis was done by the intention to treat method. As the difference between IBDDAM before and after treatment had normal distribution Student T test for paired samples were used to evaluate the outcome in the colchicine and the placebo group. As the Levene's test showed the homogeneity of variance, ANOVA (one way) was used to test the effect of treatment (colchicine and placebo) and gender on patients' outcome. The dependent variable was the difference between IBDDAM (before and after the treatment). The independent variables were the treatment, and the gender. SPSS 15 was used for all statistical calculations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: ColchicinePatients who received Colchicine and went on placebo after 4 months |
| Placebo | Placebo comparator | Drug: PlaceboPatients who received placebo and went on Colchicine after 4 months |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patient's who fulfilled the International Criteria for Behcet's Disease.
Key exclusion criteria (2 listed)
- major organ involvement
- Hypersensitivity reaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineAlso: Modacine100 mg Colchicine per day for 4 months | Drug | Colchicine |
| PlaceboOne tablet placebo per day for 4 months | Drug | Placebo |
Primary outcome
Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM)
Time frame: 8 months
5 secondary outcomes
Oral Aphthosis
Time frame: 8 months
Genital Aphthosis
Time frame: 8 months
Psuedofolliculitis
Time frame: 8 months
Erythem Nodusom
Time frame: 8 months
Joint Manifestations
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2008.
- Derived from this study: PubMed 20704622Davatchi F, Shams H, Rezaipoor M, Sadeghi-Abdollahi B, Shahram F, Nadji A, Chams-Davatchi C, Akhlaghi M, Faezi T, Naderi N. Rituximab in intractable ocular lesions of Behcet's disease; randomized single-blind control study (pilot study). Int J Rheum Dis. 2010 Aug;13(3):246-52. doi: 10.1111/j.1756-185X.2010.01546.x.
- Derived from this study: PubMed 19597921Davatchi F, Sadeghi Abdollahi B, Tehrani Banihashemi A, Shahram F, Nadji A, Shams H, Chams-Davatchi C. Colchicine versus placebo in Behcet's disease: randomized, double-blind, controlled crossover trial. Mod Rheumatol. 2009;19(5):542-9. doi: 10.1007/s10165-009-0200-2. Epub 2009 Jul 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fereydoun Davatchi, Professor study chair
Rheumatology Research Center, Tehran University for Medical Sciences
Bahar Sadeghi, MD principal investigator
Rheumatology research Center, Tehran University for Medical Sciences
Arash Tehrani Banihashemi, MD, MPH principal investigator
Rheumatology Research Center, Tehran University for Mrdical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine in people with Behcet's Syndrome, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM) (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00700297, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2008.