Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00700297

Collaborator

(none)

169

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Behcet's Syndrome	Drug: Colchicine Drug: Placebo	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

169 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet's Disease

Study Start Date :

Aug 1, 2002

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

May 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Colchicine Patients who received Colchicine and went on placebo after 4 months	Drug: Colchicine 100 mg Colchicine per day for 4 months Other Names: Modacine
Placebo Comparator: Placebo Patients who received placebo and went on Colchicine after 4 months	Drug: Placebo One tablet placebo per day for 4 months

Arm

Intervention/Treatment

Active Comparator: Colchicine

Patients who received Colchicine and went on placebo after 4 months

Drug: Colchicine

100 mg Colchicine per day for 4 months

Other Names:

Modacine

Placebo Comparator: Placebo

Patients who received placebo and went on Colchicine after 4 months

Drug: Placebo

One tablet placebo per day for 4 months

Outcome Measures

Primary Outcome Measures

Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM) [8 months]

Secondary Outcome Measures

Oral Aphthosis [8 months]
Genital Aphthosis [8 months]
Psuedofolliculitis [8 months]
Erythem Nodusom [8 months]
Joint Manifestations [8 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient's who fulfilled the International Criteria for Behcet's Disease.

Exclusion Criteria:

major organ involvement
Hypersensitivity reaction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rheumatology research Center, Tehran UMS	Tehran		Iran, Islamic Republic of	14114

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Chair: Fereydoun Davatchi, Professor, Rheumatology Research Center, Tehran University for Medical Sciences
Principal Investigator: Bahar Sadeghi, MD, Rheumatology research Center, Tehran University for Medical Sciences
Principal Investigator: Arash Tehrani Banihashemi, MD, MPH, Rheumatology Research Center, Tehran University for Mrdical Sciences
Principal Investigator: Farhad Shahram, Professor, Rheumatology Research Center, Tehran University for Medical Sciences