| CTRI Number |
CTRI/2012/12/003205 [Registered on: 11/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
30/05/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of drug, CF101 Administered Orally as Monotherapy for 12 Weeks in Patients with Active Rheumatoid Arthritis |
|
Scientific Title of Study
|
A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Daily CF101 Administered Orally as Monotherapy for 12 Weeks to Patients with Active Rheumatoid Arthritis and Elevated Baseline Expression Levels of Peripheral Blood Mononuclear Cell A3 Adenosine Receptors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CF101-204RA Amendment 8: 02 May 2012 (India-Specific) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amita Birla |
| Designation |
Associate Director- Clinical Operations |
| Affiliation |
Karmic Lifesciences |
| Address |
802, Bldg 3, Raheja Mindspace,
Airoli SEZ, Airoli
Mumbai
MAHARASHTRA
400708
India |
| Phone |
022-61170408 |
| Fax |
022-61170499 |
| Email |
amita.birla@karmiclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Birla |
| Designation |
Associate Director- Clinical Operations |
| Affiliation |
Karmic Lifesciences |
| Address |
802, Bldg 3, Raheja Mindspace,
Airoli SEZ, Airoli
Mumbai
MAHARASHTRA
400708
India |
| Phone |
022-61170408 |
| Fax |
022-61170499 |
| Email |
amita.birla@karmiclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Nelugal |
| Designation |
Project Manager |
| Affiliation |
Karmic Lifesciences |
| Address |
802, Bldg 3, Raheja Mindspace,
Airoli SEZ, Airoli
Mumbai
MAHARASHTRA
400708
India |
| Phone |
022-61170408 |
| Fax |
022-61170499 |
| Email |
shreya.nelugal@karmiclifesciences.com |
|
|
Source of Monetary or Material Support
|
| CanFiteBioPharma Ltd
10 Bareket St.
PetachTikva,Israel
|
|
|
Primary Sponsor
|
| Name |
CanFiteBioPharma Ltd |
| Address |
10 Bareket St.
PetachTikva,Israel
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Karmic Lifesciences |
802, Building No. 3,
Raheja Mind Space (SEZ), Plot No. 3,
TTC Industrial Area,
Airoli, Navi Mumbai - 400708
|
|
|
Countries of Recruitment
|
Bulgaria
Israel
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arvind Chopra |
Arthritis Research and Care Foundation Center for Rheumatic Diseases |
Department of Rheumatology,No. 11, Hermes Elegance, 1988, Convent Street Camp, Pune-411 001
Pune
MAHARASHTRA |
20-26345624
20-26334756
crdp@vsnl.net |
| Dr Jyotsana Oak |
Kokilaben Dhirubhai Ambani Hospital |
Department of Rheumatology,Four Bunglows, Rao Saheb Achutrao Patwardhan Marg, Andheri (W)
Mumbai
MAHARASHTRA |
22-30666666
22-30972030
jyotsna.oak@relianceada.com |
| Dr B R Bagaria |
Malpani Multispeciality Hospital |
Department of Rheumatology,Road No.1, VKJ Sikar Road, Jaipur, Rajasthan – 332001, India
Jaipur
RAJASTHAN |
141-2261315
141-2334612
dr.bagaria@yahoo.co.in |
| Dr Shashank kerkar |
Mumbai Arthritis Clini and Research Centre |
Department of Rheumatology, Shop 15, Wing I, Bldg 2,
Mayuresh Srishti, opp. Asian paints, LBS Road,
Bhandup (west)
Mumbai
MAHARASHTRA |
09987027751
91-022-25946624
shashank77_2000@yahoo.com |
| Dr Firdaus Fatima |
Olive Hospital |
Department of Rheumatology,12-2-718/3-5, Nanalnagar X Roads, Mehdipatnam, Hyderabad-500028, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH |
40-30499500
40-23511320
firdaus674@yahoo.com |
| Dr U R K Rao |
Sri Deepti Rheumatology Centre |
Department of Rheumatology,6-2-45/8, A. C. Guards, Hyderabad- 500 004, India
Hyderabad
ANDHRA PRADESH |
40-23395684
40-23379432
urkrao@yahoo.com |
| Dr Nandini Babhulkar |
Sushrut Hospital |
Department of Rheumatology,Research Centre and Post Graduate Institute of Orthopedics, 30-B, Central Bazar Road, Ramdaspeth, Nagpur- 440010, India
Nagpur
MAHARASHTRA |
712-2424062
712-2430065
nandinishush@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Clinical Ethics Forum, Mumbai for Dr. Shashank Akerkar |
Approved |
| CRD Ethics Committee for Arthritis Research and Care Foundation, Center for Rheumatic Diseases |
Approved |
| Independent Ethics Committee, Jaipur and Dr. B R Bagaria |
Approved |
| Institutional Ethics Committee of Kokilaben Dhirubhai Ambani Hospital |
Approved |
| Sri Deepti Rheumatology Centre Ethics Committee, Hyderabad for Dr. Firdaus Fatima |
Approved |
| Sri Deepti Rheumatology Centre Ethics Committeed for Sri Deepti Rheumatology |
Approved |
| Sushrut Hospital Ethics Committee for Sushrut Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Active Rheumatoid Arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CF101 1 mg |
CF101 1 mg tablets q12 hours orally for 12 weeks |
| Comparator Agent |
Placebo |
Matching placebo tablets q12
hours orally for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females ages 40-65 years
2. Meet the criteria of the American College of Rheumatology for RA (Arnett FC et al. Arthritis Rheum 1988;31:315-324, Appendix 1)
3. Not bed- or wheelchair-bound
4. Active RA, as indicated by the presence of (a)6 swollen joints (28 joint count); AND (b) 6 tender joints (28 joint count); AND either: (c) Westergren ESR of 28 mm/hour; OR (d) CRP level above the upper limit of normal for the central reference laboratory
5. Elevated PBMC A3AR expression level, defined as 1.5-fold over a predetermined normal population standard within 2 weeks of beginning dosing
6. If taking a nonsteroidal anti-inflammatory agent (NSAID), dose has been stable for at least 1 month prior to the A3AR Qualification Visit, and will remain unchanged during protocol participation
7. If taking an oral corticosteroid, dose is 10 mg/day prednisone or equivalent, has been stable for at least 1 month prior to the A3AR Qualification Visit, and will remain unchanged during protocol participation
8. In the Investigator’s opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol
9. Negative screening serum pregnancy test for female patients of childbearing potential
10. Females of childbearing potential must utilize, throughout the course of the trial, 2 methods of contraception deemed adequate by the Investigator (for example, oral contraceptive pills plus a barrier method)
11. All aspects of the protocol explained and written informed consent obtained
|
|
| ExclusionCriteria |
| Details |
1. Receipt of any of the following for at least a 1 month washout period prior to the A3AR Qualification Visit: methotrexate, sulfasalazine, oral or injectable gold, azathioprine, minocycline, penicillamine, anakinra
2. Receipt of etanercept for at least a 6 week washout period prior to the A3AR Qualification Visit
3. Receipt of chloroquine, hydroxychloroquine, cyclosporine, infliximab, golimumab or adalimumab for at least a 2 month washout period prior to the A3AR Qualification Visit
4. Receipt of leflunomide for at least a 2 month washout period prior to the A3AR Qualification Visit, unless patient has undergone cholestyramine washout at least 1 month prior to testing
5. Receipt of cyclophosphamide for at least a 6 month period prior to the A3AR Qualification Visit
6. Receipt of rituximab at any previous time
7. Previous failure to respond to methotrexate or any anti-rheumatic biological agent (Not applicable for subjects from India)
8. Participation in a previous trial CF101 trial
9. Use of oral corticosteroids 10 mg of prednisone, or equivalent, per day
10. Change in NSAID dose level for 1 month prior to the A3AR Qualification Visit
11. Change in oral corticosteroid dose level during the 1 month prior to the A3AR Qualification Visit
12. Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to the A3AR Qualification Visit
13. Presence or history of uncontrolled arterial hypertension or symptomatic hypotension
14. Significant cardiac arrhythmia or conduction block, congestive heart failure, or any other evidence of clinically significant heart disease; other clinically significant findings on screening electrocardiogram (ECG)
15. Hemoglobin level 9.0 gm/dL at the screening visit
16. Platelet count 125,000/mm3 at the screening visit
17. White blood cell count 3000/mm3 at the screening visit
18. Serum creatinine level outside the central laboratory’s normal limits at the screening visit
19. Liver aminotransferase (ALT and/or AST) levels greater than 2 times the central laboratory’s upper limit of normal at the screening visit
20. Known or suspected immunodeficiency, including a Screening serum globulin value of 2.0 g/dL, or human immunodeficiency virus positivity
21. Pregnancy, lactation, or inadequate contraception as judged by the Investigator
22. Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to screening
23. History of active drug or alcohol dependence
24. History of malignancy within the past 5 years (excluding excised basal or squamous cell carcinoma of the skin)
25. Diagnosis of Parkinson’s Disease
26. Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient’s ability to complete the study, and/or compromise the objectives of the study
Additional India-specific Exclusion Criteria:
27. Prior receipt of any DMARD, including but not limited to those mentioned in the Exclusion Criteria 1-6 above
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ACR 20 Response at the Week 12 visit using non-responder imputation |
At the Week 12 visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ACR 20/50/70 Responses over time [ITT, LOCF], mean changes in individual components of the ACR response criteria, DAS28, EULAR responses, and biomarkers |
4 times i.e. at visit 2,4,8 and 12 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/06/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
25/08/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study. Approximately 80 patients will be enrolled, with the expectation of randomizing 40 patients to each of the 2 treatment groups. Enrollment will occur at sites in countries that may include Israel, Bulgaria, India. |