| CTRI Number |
CTRI/2013/10/004040 [Registered on: 01/10/2013] Trial Registered Prospectively |
| Last Modified On: |
20/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate efficacy, tolerability and safety of Adalimumab (Zydus) and Adalimumab (Reference) in patients with Rheumatoid Arthritis.” |
|
Scientific Title of Study
|
“A multicentric, randomized, active controlled parallel group study to evaluate efficacy, tolerability and safety of Adalimumab (Zydus) and Adalimumab (Reference) in patients with Rheumatoid Arthritis.” |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| ADA.12.002.01.PROT(Version -1.0 dated 27th April 2013) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R H jani |
| Address |
Zydus Cadila House,Plot no.360, TPS 5, Service road, Vile Parle (East)
Mumbai,India
Mumbai
MAHARASHTRA
400057
India |
| Phone |
26186052 |
| Fax |
26151735 |
| Email |
rhjani@zyduscadila.com |
|
Details Contact Person
Scientific Query
|
| Name |
Dr R H jani |
| Address |
Zydus Cadila House,Plot no.360, TPS 5, Service road, Vile Parle (East)
Mumbai,India
MAHARASHTRA
400057
India |
| Phone |
26186052 |
| Fax |
26151735 |
| Email |
rhjani@zyduscadila.com |
|
Details Contact Person
Public Query
|
| Name |
Dr R H jani |
| Address |
Zydus Cadila House,Plot no.360, TPS 5, Service road, Vile Parle (East)
Mumbai,India
MAHARASHTRA
400057
India |
| Phone |
26186052 |
| Fax |
26151735 |
| Email |
rhjani@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Limited |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House,2nd Floor,Plot No.360,T.P.S.5,service road,Vile parle(E),mumbai 400057 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uma Kumar |
AIIMS, Delhi |
Room No 4076, Department of Medicine, AIIMS, Ansari Nagar, South Extension, New Delhi- 110029.
New Delhi
|
9868397253
umaakumar@yahoo.co.in |
| Dr Girish Bartakke |
B J Govt. Medical College ,Pune |
Department of Orthopaedics, B J Govt. Medical College and a Nursing -COllege and Sassoon Hospital. Near Pune Railway Station. Pune-411 001
Pune
|
9422036065
girishbartakke@rediffmail.com |
| Dr Dinesh Jain |
Dayanand Medical College and Hospital |
Department of Medicine,
Dayanand Medical College and Hospital,D.M.C.Road, Togore Nagar,
Ludhiana – 141001
Ludhiana
|
9815532533
dineshdmc@gmail.com |
| Dr P Ashok Kumar |
King George Hospital |
Department of Orthopedics, Unit 2. King George Hospital, Visakhapatnam - 530002, AP, India
Visakhapatnam
|
9849123602
ashok_ortho59@rediffmail.com |
| Dr Rajiv Gupta |
Malpani Multispeciality hospital |
Malpani Multispeciality hospital, Road No-1, V K I, Jaipur-32013
Jaipur
|
9414980697
drrajivg77@gmail.com |
| Dr Girish Bhatia Golkuldas |
Medipoint Hospitals Pvt. Ltd |
Medipoint Hospitals Pvt. Ltd, 241/1, New D. P. Road, Aundh, Pune-411007, Maharashtra, India
Pune
|
020-40098635
drbhatia.pentagon@gmail.com |
| Dr Gaurav Rathi |
Rathi Orthopaedic & Research Centre |
Rathi Orthopaedic & Research Centre, Nr. Anupam Shopping Centre, Opp. Mahabaleshwar Socity, Jodhpur cross road, Satellite, Ahmedabad 380015, Gujarat .
Ahmadabad
|
079-26924810
drgjrathi@yahoo.co.in |
| Dr Liyakat Ali Gauri |
S P Medical College and associated Group of Hospi |
S P Medical College and associated Group of Hospital, Bikaner-334001,Rajasthan
Bikaner
|
9829795116
drliyakatgauri@rediffmail.com |
| Dr Reena Sharma |
Shalby Hospital |
Shalby Hospitals, Opp. Karnavati Club, S. G. Highway, Ahmedabad- 380 015
Ahmadabad
|
079-40203148
reena.sharma@shalby.org |
| Dr Praveen Jadhav |
Sujata Birla Hospital and Medical Research Center |
Sujata Birla Hospital and Medical Research Center, Opp. Bytco College, Nashik Road, Nashik – 422101
Nashik
|
9822055612
drpraveenj@sify.com |
| Dr Vikram Haridas |
Sushrusta Multispeciality Hospitals & Research Centre |
Sushrusta Multispeciality Hospitals & Research Centre Pvt Ltd. Vidyanagar,P. B Road, Hubli-Karnataka
Belgaum
|
918362369883
haridasvikram@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee ,S P Medical college and A G Hospitals,Bikaner |
Approved |
| Ethics Committee,Shalby Hospital |
Approved |
| Institute Ethics committee,All India Institute of medical sciences |
Approved |
| Institutional Ethics Committe,King george hospital Vi |
Approved |
| Institutional Ethics committee |
Approved |
| Institutional Ethics Committee,Dayanand Medical college and hospital,Ludhiana |
Approved |
| Institutional Ethics Committee,Malpani Multispeciality hospital |
Approved |
| Penta Med Ethics Committee |
Approved |
| Rathi Ethics Committee |
Approved |
| Sushruta Hospital Ethics Committee |
Approved |
| Yash Society Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Rheumatoid arthritis, unspecified |
| Patients |
Rheumatoid arthritis. |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Adalimumab (Abbott) |
Route:-Subcutaneous
Dose:-40mg Dosage:-subcutaneous injection every other week
Duration :-3 months |
| Intervention |
Adalimumab (Zydus) |
Route:-Subcutaneous
Dose:-40mg
Dosage:-subcutaneous injection every other week
Duration:-3 months
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults subjects of either gender in age group of ≥ 18 year and ≤65 years.
2. History of rheumatoid arthritis, as defined by the American College of Rheumatology (ACR) Classification1, for atleast 6 months.
3. Moderate to severe active seropositive disease.
4. History of treatment with Methotrexate (MTX) 10-25mg per week for atleast 12 weeks with last 4 weeks at the stable dose before screening.
5. If female and of childbearing potential, she shall have a negative pregnancy test at the time of screening and agrees to use adequate contraception throughout the study period.
6. Able and willing to give written informed consent and comply with the requirements of the study protocol.
|
|
| ExclusionCriteria |
| Details |
1. Patients with significant systemic manifestations of RA.
2. Female nursing patients.
3. Rheumatic autoimmune disease other than RA.
4. History of diagnosis of juvenile idiopathic arthritis (JIA) (also known as juvenile rheumatoid arthritis [JRA]) and/or RA before age 16.
5. History of inflammatory arthritis other than RA (e.g., inflammatory bowel disease (IBD), systemic lupus erythematosus (SLE), or psoriatic arthritis).
6. Any surgical procedure, including bone/joint surgery or planned surgery within 8 weeks prior to screening or during the study period.
7. Functional Class IV as defined by the American College of Rheumatology (ACR) classification of functional status in RA2.
8. History of use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeks prior for leflunomide).
9. Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer).
10. Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab.
11. Use of intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit. Inhaled corticosteroids for stable medical conditions are allowed.
12. Receipt of a vaccine within 4 weeks prior to enrolment visit.
13. History of severe allergic or anaphylactic reactions to latex
14. History of primary or secondary immunodeficiency.
15. Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary disease, including any pulmonary or other condition that would preclude subject participation.
16. Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds).
17. History of travel to areas endemic for mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis.
18. History of recurrent significant infection or any significant episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
19. History of cancer, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinoma of the skin that have been excised and cured).
20. Lack of peripheral venous access.
21. History of chronic daily use of narcotic analgesics.
22. History of alcohol, drug, or chemical abuse within 6 months prior to screening.
23. Positive Hepatitis B surface antigen or antibodies to Hepatitis C.
24. History of significant cytopenias or other bone marrow disorders.
25. Laboratory Exclusion Criteria: Patients may not participate in this study until any of the following that are present have resolved.
a. Serum creatinine > 1.4 mg/dL for women or 1.6 mg/dL for men.
b. AST or ALT > 2.5 times upper limit of normal (UNL).
c. Platelet count < 100,000/µL.
d. Hemoglobin < 8.0 g/dL.
e. Neutrophil < 1.5 × 103/µL. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Pharmacodynamic (efficacy) of Adalimumab (Zydus) and Adalimumab (Abbott) in subjects with RA on Day 84 as compared to baseline
a) Proportion of patient with an ACR 20 response in both the treatment groups.
|
Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pharmacodynamic (efficacy) of Adalimumab (Zydus) and Adalimumab (Abbott) in subjects with RA on Day 84 as compared to baseline:-Change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS 28-CRP),Proportion of patient with an ACR 50 response in both the treatment groups,Proportion of patient with an ACR 70 response in both the treatment groups.
Immunogenicity assessment: Percentage of subjects who develop detectable anti-drug antibodies
|
Pharmacodynamic (efficacy) :-Day 84.
Immunogenicity assessment:-Day 1, Day 28 and Day 84 (Week 12). |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2013 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
Brief Summary
Modification(s)
|
This is a multicentric, randomized, active controlled parallel group study to evaluate efficacy, tolerability and safety of Adalimumab (Zydus) and Adalimumab (Reference) in patients with Rheumatoid Arthritis.”
The purpose of this study is to determine the efficacy, tolerability and safety of Adalimumab (Zydus) in patients with rheumatoid
Th subjects from either gender in age group of ≥ 18 to ≤65 years with History of rheumatoid arthritis, as defined by the American College of Rheumatology (ACR) Classification1, for at least 6 months, Moderate to severe active seropositive disease., History of treatment with Methotrexate (MTX) 10-25mg per week for atleast 12 weeks with last 4 weeks at the stable dose before screening will be invited to participate in this study. |
