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CTRI Number  CTRI/2015/09/006201 [Registered on: 18/09/2015] Trial Registered Prospectively
Last Modified On: 21/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to assess the Effect and Safety of Tacrolimus Lipid Tablets Compared to Tacrolimus simple Tablets in Adult Patients with Rheumatoid Arthritis Who are not responding to conventional medications 
Scientific Title of Study   A Randomized, Double Blind, Multi Center, Parallel Study to Evaluate the Efficacy and Safety of Tacrolimus Lipid Tablets (Manufactured By Intas Pharmaceuticals Ltd) Compared to Prograf (Tacrolimus Immediate Release Capsules-Astellas Pharma Canada, Inc) in Adult Patients with Active Rheumatoid Arthritis Who Have Resistance OR Intolerance to DMARDs.  
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
113-14, Version: 03, Date: 07/05/2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravi Panchal 
Designation  Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India 
Phone  07940202564  
Fax  07940202021  
Email  raviapanchal@lambda-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Randhirsinh Solanki 
Designation  General Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India 
Phone  07940202070  
Fax  07940202021  
Email  randhirsinh@lambda-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravi Panchal 
Designation  Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India 
Phone  07940202564  
Fax  07940202021  
Email  raviapanchal@lambda-cro.com  
 
Source of Monetary or Material Support  
Intas Pharmaceuticals Ltd. 2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad 380009, Gujarat, India Tel. No.: 07926576655 
 
Primary Sponsor  
Name  Intas Pharmaceuticals Ltd 
Address  2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad 380009, Gujarat, India Tel. No.: 07926576655 Fax: 07926578862 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Liyakat Ali Gauri  S.P Medical College & AG of Hospitals  Department of Medicine (Rheumatology unit)-334003
Bikaner
RAJASTHAN 		 9782200231

info@siaramresearch.com 
Dr Putta Kempa Raju  Bangalore Medical College and Research Institute  Room # 35, Department of Orthopaedics, Ground floor, OPD ‘B’ Block, Victoria Hospital, BMCRI Fort, KR Road-560002
Bangalore
KARNATAKA 		 9845172978

kvpkr@rediffmail.com 
Dr Smruti Ramteke  Jasleen hospital  opp.Big Bazar, Panchsheel square, Dhantoli- 440012
Nagpur
MAHARASHTRA 		 9823514650

sramteke@rediffmail.com 
Dr Siddhartha Kumar Das  King Georges Medical University   King Georges Medical University Chowk, Shah Mina Rd-226003
Lucknow
UTTAR PRADESH 		 9335902776

rheumatologykgmu@gmail.com 
Dr Bhatia Girish Gokuldas  Medipoint Hospitals Pvt Ltd  241/1, New D P Road, Aundh, -411007
Pune
MAHARASHTRA 		 7387003636

drbhatia.pentagon@gmail.com 
Dr Sharad Prahladbhai Purohit   Sanjivani Super Speciality Hospitals Private Limited  1, Uday Park Society, Vastrapur, Near Sunrise Park, Vastrapur-380051
Ahmadabad
GUJARAT 		 9879007908

dr_sharadpurohit@hotmail.com 
Dr Ashish Pongde  Shree Hospital & Critical Care Centre  799, Om Nagar, Opp. Tajshree Building, Sakkardara Sqr.- 440009
Nagpur
MAHARASHTRA 		 9850853253

ashishpongde@gmail.com 
Dr Mohan N S  Sri Venkateshwara Hospital  86, Hosur Main Road, Madiwala - 560068
Bangalore
KARNATAKA 		 08025630006

svhospital1997@gmail.com 
Dr Praveen Pratap Jadhav  Sujata Birla hospital & Medical Research Centre  Opposite Bytco college, Nashik Pune road-422101
Nashik
MAHARASHTRA 		 9822055612

drpraveenjadhav@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Institutional Ethics Committee, Jasleen hospital, Dr Smruti Ramteke  Submittted/Under Review 
Ethics Committee of Bangalore Medical College and Research Institute, Dr Putta Kempa Raju  Approved 
Ethics Committee, S.P Medical College & A.G Hospitals, Dr Liyakat Ali Gauri  Submittted/Under Review 
Institutional Ethics Committee, King Georges Medical University, Dr Siddhartha Kumar Das  Submittted/Under Review 
Pentamed Ethics Committee, Medipoint Hospitals Pvt Ltd., Dr Bhatia Girish Gokuldas  Submittted/Under Review 
Sanjivani Hospitals Ethics Committee, Dr Sharad Prahladbhai Purohit  Submittted/Under Review 
Shree Hospital Ethics committee, Dr Ashish Pongde  Submittted/Under Review 
Sri Venkateshwara Hospital Ethics Committee, Dr. Mohan N. S  Submittted/Under Review 
Yash Society Institutional Ethics Committee, Dr Praveen Pratap Jadhav  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Prograf Capsule _Astellas Pharma  Dose: 3 mg, Frequency: Once daily, Mode of Administration: Orally, Duration of treatment: 16 weeks 
Intervention  Tacrolimus lipid tablets_Intas  Dose: 2 mg & 3 mg, Frequency: Once daily, Mode of Administration: Orally, Duration of treatment: 16 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient willing to give written, signed and dated informed consent to participate in the study before initiating any study related procedures

2. Adult patients of age 18 years or older who should meet the criteria for Rheumatoid Arthritis as per American College of Rheumatology at least for last 6 months with ACR functional class I–III

3. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, emale condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during tudy and up to 30 days after the last dose of study drug

4. In case of Male patients: Either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug

5. No other serious illness that according to investigator might jeopardize the well-being, the safety of patients, the compliance to study medications and validity of data generated during the study.
 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to Tacrolimus or any of its components

2. Patients who had received biological products with an inhibitory effect on the progression of joint destruction (e.g. Infliximab, etanercept) within 12 weeks before administration of the study drug

3. Patients who had previously received Tacrolimus for current disease

4. Pregnant or breast-feeding female

5. Clinically significant Liver disease (defined by levels of Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, or Total bilirubin ≥2 times the upper limit of normal)

6. Clinically significant renal disease (defined by serum creatinine (Cr) ≥2 times the upper limit of normal)

7. Clinically significant Bone marrow suppression defined as haemoglobin level <9 gm/dl, white blood cell count < 3,000/mm3, platelet count <100,000/mm3

8. Patients with Hepatitis B or C infection

9. Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders.

10. Have any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion

11. Have participated in a study of an investigational drug during the 30 days preceding randomization  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Evaluation will be done by the ACR 20% response level of improvement (ACR20) at the end of treatment.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety of the patients who are exposed to investigational medicinal products  6 months 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/10/2015 
Date of Study Completion (India) 16/11/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Rheumatoid arthritis (RA) is a chronic progressive inflammatory disease characterized by swelling and pain in multiple joints. Recent guidelines for the management of RA have reinforced the primary treatment aim which is disease remission in order to reduce the structural and functional impact of the disease. The outlook for patients with rheumatoid arthritis has improved significantly over the last  three decades with the use of disease-modifying antirheumatic drugs. However, despite the use of methotrexate, cytokine inhibitors, and molecules targeting T and B cells, a percentage of patients do not respond or lose their  response over time. Because of the known role of T cell activation in disease pathogenesis, the observed immunomodulating actions of tacrolimus, and the encouraging results of many clinical trials led us to develop Tacrolimus in RA. Tacrolimus is an immunomodulator that acts by inhibiting T-cell activation. A number of clinical studies have been reported over the last decade supporting its use in RA. Tacrolimus tablets are manufactured using lipidic  excipients like Soy Phosphotidyl Choline & Sodium Chloesteryl Sulfate. These excipients are Generally Regarded as Safe (GRAS) by United State Food & Drug Administration (US FDA).  
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