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Basic Research Activities
 
>> Application of Bioinformatics in the area of Psychoneuroimmunology   ONGOING
>> Development of Blot method for Anti Proteus mirabilis antibodies   COMPLETED
>> Development of Simple Method to Detect Malarial Parasites Invitro from Whole Blood.   ONGOING
>> Genetic /DNA Analysis of Family with RA Its Relationship and Rheumatoid Factor   ONGOING
>> Incidence of Anti-CCP, Rheumatoid Factor in first degree relatives of Rheumatoid Arthritis Patients   ONGOING
 
Clinical Trial Projects:
 

Sr.
No.

Clinical Trial Projects Title

Year

Study
Period

RECURITMENT STATUS

Study
On

1

 

A Multicenter, Randomized, Double – Blind, Placebo controlled trials of Golimumab, a Fully Human Anti-TNF a Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve subjects with Active Rheumatoid Arthritis

2006
ONGOING

5 Year

CLOSED

RA

2

 

A Randomized, Open label, Four Arms Parallel Study to Evaluate the Safety and Efficacy of anti-CD6 monoclonal antibody (T1hMAb) in Combination with B9
CTRI No.and Date CTRI/2008/091/000295, 22-12-2008
UTRN.WHO  TEMP UTRN 110159200-19122008397753

2006
COMPLETED

1 Year

CLOSED

RA

3

 

Double-blind, triple dummy, parallel-group, randomized, six month study to compare Celecoxib (200 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events.  Protocol A3191084" from the sponsor company Pfizer Limited. 

2007
COMPLETED

6 Months

CLOSED

OA

4

 

A phase II, randomized, double-blind, placebo-controlled, Parallel- group study to assess the safety and efficacy of Maraviroc (uk-427,857) in the treatment of rheumatoid Arthritis in subjects receiving Methotrexate for protocol No A4001056

2006
COMPLETED

2 Years

CLOSED

RA

5

 

A Phase IIIB, Multi-Center, Randomized, Double-Blind, Double-Dummy Study to compare the efficacy and safety of Abatacept administered Subcutaneously and  Intravenously in subjects with Rheumatoid Arthritis, receiving background Methotrexate, and experiencing an Inadequate response to Methotrexate.

2006
ONGOING

3 Year

CLOSED

RA

6

 

A Multicenter, randomized, double blind, placebo controlled study, comparing the efficacy and safety of BioCell Collagen II ® 1000 mg twice daily as compared with glucosamine sulfate 750 mg twice daily, biofermented hyaluronic acid 100 mg twice daily, glucosamine HCL 750 mg + chondroitin sulfate 600 mg twice daily and placebo twice daily in subjects with osteoarthritis.

2008
ONGOING

6 Months

CLOSED

OA

7

 

Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80mg, 160mg, and 320mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate – ALD518-CLIN-003

2007
COMPLETED

1 year

CLOSED

RA

8

 

A Multi-Center, Randomized, Double -Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Uprate Lowering Therapy.

2008
ONGOING

6 Months

CLOSED

GOUT

9

 

A Multi-Center, Randomized, Double -Blind, Placebo Controlled Trial of the Efficacy and  Safety of  Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy.

2008
ONGOING

6 Months

CLOSED

GOUT

10

 

Study Title: An open label, non-comparative study to evaluate the efficacy, safety, and tolerability of Lornoxicam 8 mg tablet in the treatment of Rheumatoid Arthritis. CTRI No.and Date CTRI/2009/091/000297, 24-07-2009
UTRN.WHO TEMP UTRN 030232938-200520097411059

2009
ONGOING

3 Months

CLOSED

RA

11

 

Multi-National Open-Label Study to Evaluate the safety, Tolerability and efficacy of Tocilizumab in patients with Active Rheumatoid Arthritis on background Non-biologic DMARDs who have an Inadequate Response to current Non-biologic DMARD and/or Anti TNF Therapy

2009
COMPLETED

6 Months

CLOSED

RA

12

 

A Phase IIA, Randomized, Double Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012When Given with Methotrexate to Subjects With Active Rheumatoid Arthritis who have had an Inadequate response to Conventional Disease Modifying Anti-rheumatic drug therapy
CTRI/2009/091/000642, 27-08-2009
TEMP UTRN 102429886-120820091108970

2008
COMPLETED

6 Months

CLOSED

RA

13

 

A Phase III , Multi-center, randomized double blind, controlled study of the long term analgesic efficacy and safety of Tanezumab alone or in combination with non-steroidal anti-inflammatory drugs(NSAIDs)versus NSAIDs alone in patients with osteoarthritis of the knee or hip.
CTRI/2009/091/000405, 25-06-2009
TEMP UTRN 064015006-190620098621180

2009
ONGOING

1 Year

CLOSED

OA

14

 

A multicenter, phase III, single arm, open label trial of the efficacy and safety of certolizumab pegol given subcutaneously as an adjunctive medication to methotrexate in the treatment of rheumatoid arthritis in Indian subjects who have an inadequate response to methotrexate

2007
COMPLETED

2 Years

CLOSED

RA

15

 

“Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of CP-690,550 in Patients with Active Rheumatoid Arthritis on Background Methotrexate
UTRN.WHO  TEMP UTRN 113817210-2807200910601180
CTRI No.and Date CTRI/2009/091/000596, 29-07-2009

2008
Approved

2 Years

CLOSED

RA

16

 

A Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821, (an Anti-IL-17Antibody) in Patients with Active Rheumatoid Arthritis on Concomitant DMARD Therapy.
CTRI/2009/091/000777, 11-01-2010
TEMP UTRN 114017134-1709200912531078

2009
ONGOING

1 Year

CLOSED

RA

17

Long terms, open label, follow up study of CP690-550. A Moderately selective Janus-Kinase-3 inhibitor for treatment of Rheumatoid Arthritis

2010
ONGOING

2 Years

CLOSED

RA

18

An Open label, prospective, non-comparative, multicentre study to assess the safety and efficacy of Etanarcept for injection 25mg in patients with moderate to severe active rheumatoid arthritis.

2009
ONGOING

6 Months

CLOSED

RA

19

 

A Prospective Observational Study to Evaluate Long-Term Safety and Functional Status of Subjects with Rheumatoid Arthritis Previously Enrolled in Studies of CP-690,550”

2010
ONGOING

2 Years

ONGOING

RA

20

Cytokine in Tuberculosis and contacts can it predict the outcome?

2010
APPROVED

6 Months

ONGOING

TB

21

A study to ascertain the population prevalance of Rheumatic diseases in Bangalore Urban area

2010
APPROVED

6 Months

ONGOING

RA

22

D4300C00002 : (OSKIRA-2): Multi-Centre, Randomised, Double Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs

2010
Approved

1 Year

ONGOING

RA

23

(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis

2010
Approved

1 Years

ONGOING

RA

24

NA22823 B: A phase II/III seamless, multicentre, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with Tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naive to TNF antagonist theraphy

2010
Approval Awaited

5 Years

ONGOING

AS

25

14V-MC-JADA A randomized, double-blind, placebo-controlled, dose-ranging , parallel-group, phase 2b study of LY 3009104 in patients with Active Rheumatoid Arthritis on background Methotrexate  theraphy

2010 APPROVED

6 Months

ONGOING

RA

26

An Open-label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-modifying Antirheumatic Drug (DMARD) Therapy in Biologic-naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)
CTRI No.and Date CTRI/2009/091/000883, 23-11-2010
UTRN.WHO  TEMP UTRN 061615108-271020091367923

Approved
2010

1 Year

CLOSED

RA

27

GP13,-201"A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficicacy of GP13-201 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or two anti-TNF therapies"

IN THE PIPELINE
2010

1 Year

Yet to
Approved

RA

 
 
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