Objectives: The beneficial effects of both drugs, immunosuppressive drugs are pamidronate and improve clinical protests in patients with Ankylosing Spondylitis has been shown in many studies, but whether Pamydronate with fewer side effects can be a good alternative for immunosuppressive drugs safety, is questionable. This study aimed to investigate the effect of a drug class will be conducted.
Design: This study is a randomized controlled trial.
Setting and conduct: The samples included patients with a final diagnosis of ankylosing spondylitis (with the classification criteria New York) to receive care and treatment in the clinic of Rasoule Akram hospital During the year 1395 in Tehran were randomly divided into two groups (the intervention and control group).
Inclusion criteria: None of the patients had not received until study drug, and PPD test and Viral markers were negative in them.
Exclusion criteria: the occurrence of side-effects and the unwillingness of the patient to continue treatment
Intervention : Study participants were randomly assigned to two groups received therapy with Pamidronate 90 mg IV for 6 months (n = 25) or medications that suppress the immune system based on standard protocols (n=16).
Main outcome measures: To determine the effects of the questionnaire (BASDAI), and (BASFI), and evaluation of Health Questionnaire (HAQ) at two time points at baseline and after six months and laboratory tests such as the Erythrocyte sedimentation rate (ESR) and C Protein reactive (CRP) will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030813565N3
Registration date:2017-05-06, 1396/02/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-06, 1396/02/16
Registrant information
Name
Parastoo Amiri
Name of organization / entity
Shaheed Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 2563
Email address
amiri.parasto@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-10-12, 1395/07/21
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of amidronate and immunosuppressive medications in treatment of patients with ankylosing spondylitis
Public title
Comparing amidronate and immunosuppressive medications in treatment of patients with ankylosing spondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: None of the patients were not received until study drug, PPD test and Viral markers were negative
Exclusion criteria: the occurrence of side-effects; Patient unwillingness to continue the study
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Besides Milad Tower, Shahid Hemmat Highway,
City
Tehran
Postal code
Approval date
2017-01-11, 1395/10/22
Ethics committee reference number
IR.IUMS.REC.1395.9221160001
Health conditions studied
1
Description of health condition studied
Ankylosing spondylitis
ICD-10 code
M45
ICD-10 code description
Ankylosing spondylitis
Primary outcomes
1
Description
CRP
Timepoint
0,6m
Method of measurement
labratory
2
Description
BASDAI questionnaire
Timepoint
0,6m
Method of measurement
BASDAI questionnaire
3
Description
BASFA questionnaire
Timepoint
0,6m
Method of measurement
BASFA questionnaire
4
Description
ESR
Timepoint
0,6m
Method of measurement
labratory
Secondary outcomes
1
Description
HAQ questionnaire
Timepoint
0,6
Method of measurement
questionnaire
Intervention groups
1
Description
Pamidronate 90 mg IV
Intervention group
Category
Treatment - Drugs
2
Description
Retuximab 1000mg q14days
two days
control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Clinic of Hazrate Rasool Hospital
Full name of responsible person
Dr Seyyed Mohammadreza Vaziri
Street address
Hazrate Rasool Hospital, Sattar Khan St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr seyyed Ali Javad Mousavi
Street address
Besides Milad Tower, Shahid Hemmat Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Reza Vaziri
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Hazrat-e Rasool General Hospital, Sattar Khan St, Tehran
City
Tehran
Postal code
Phone
+98 21 54351
Fax
Email
mrv6354@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Roshanak Haseminasab
Position
Assistant Professor/Internist
Other areas of specialty/work
Street address
Hazrat-e Rasool General Hospital, Sattar Khan St, Tehran
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
roshanak.h21@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Mohammadreza Vaziri
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Hazrat-e Rasool General Hospital, Sattar Khan St, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
mrv6354@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)