Research Projects

 

Dr. Prakruthi. J (Batch: July 2019 – June 2021)

Assessment of immune status in patients of SLE and related CTD on immunosuppression through immune monitoring – guideline to help the strike balance between infection and disease control

 

 

Dr. Veena Ramachandran (Batch: Jan 2019 – Dec 2020)

Analysis of the Temporal profile of illness in patients with Rheumatoid Arthritis for more than five years.

 

 

Dr. Ramakrishna Giri (Batch: July 2018 to June 2020)

Factors influencing the quality of life of patients with Rheumatoid Arthritis for more than five years, including adherence to treatment.

 

 

Dr. Shivputra Ghanti (Batch: Jan 2018 – Dec 2019)

Prospective cohort study to determine the assessment of ankylosing spondylitis with ASAS, in axial

disease DAS in peripheral arthritis and its relationship with NLR as a inflammatory marker.

 

 

Dr. Bharathraj. M. Y (Batch: July 2017 – June 2019)

Validation of outcome measures of rheumatoid arthritis patients using framed questionnaires every

week with respect to their inter-visit clinical assessment.

 

 

Dr. Murali Krishna Manukonda (Batch: Jan 2017 – Dec 2017)

To compare Neutrophil to Lymphocyte ratio with Ultrasound based joint score in patients with

Rheumatoid Arthritis in remission – Does NLR represent subclinical inflammation.

 

 

Dr. Swetha. J (Batch: Jan 2016 – Dec 2016)

To study the factors influencing treatment outcomes of psoriatic arthritis – A retrospective study from a single center.

 

 

Dr. Deepak. C. L (Batch: July 2015 – June 2016)

To evaluate the role of Neutrophil-Lymphocyte Ratio, T-Cell B-Cell Ratio and Th17/T reg Ratio as

potential markers for prediction stable remission or low disease activity (LDA) in patients with

rheumatoid arthritis in remission – An observational longitudinal study (Continuation study)

 

 

Dr. Ashwini Kamath (Batch: July 2014 – June 2015)

To evaluate the role of neutrophil lymphocyte ratio, T Cell Bcell ratio and Th17/Treg Ratio as potential

markers predicting stable remission or low disease activity (LDA) in patients with Rheumatoid Arthritis

in remission-An observational longitudinal Study

 

 

 

 

 

Dr. Sachin. V. Dhote (Batch: Jan 2014 – Dec 2014)

To Study the serum levels of homocysteine, uric acid, lipid profile and Apo-lipoprotein-A as biomarkers

of metabolic stress of inflammation in recently diagnosed cases of rheumatoid arthritis, Systemic Lupus

Erythematosus, Seronegative Spondyloarthropathy and vasculitis.

 

 

Dr. Anand. R. Patted (Batch: July 2013 – June 2014)

Estimation of total Serum Vitamin D levels in Rheumatoid Arthritis and Vitamin D supplementation in

deficiency state and evaluation of its relationship to the change in disease activity – Randomized

consent (screening), open label interventional study.

 

 

Dr. Ranjith Mohan (Batch: Jan 2013 – Dec 2013)

Monitoring of disease activity in Rheumatoid Arthritis - a prospective observational study to evaluate

the efficacy of a new questionnaire and the derived scoring system as an instrument to monitor disease

activity in Rheumatoid Arthritis in the intervals between clinical reviews

 

 

Dr. Uthkarsha .C. Narone (Batch: Jan 2013 – Dec 2013)

Is early response of Rheumatoid Arthritis to any DMARD a good predictor of clinical outcome at one

year – A Retrospective Study

 


Dr. Narayana Swamy (Batch: Jan 2011 to Dec 2011)

Relationship between stressful life events and onset of Rheumatoid Arthritis.

 

 

Dr. Arun M.S (Batch: Jan 2010 to Dec 2010)

Case Control study: Pressure pain threshold- A measure of disease activity in Rheumatoid Arthritis

 

 

Dr. Apurva Khare (Batch: Jan 2009 to Dec 2009)

Case study: Role of Psychological stress as a Triggering factor for Ankylosing Spondylitis.

 

 

 

 

Rheumatology Training Project

 

 

Dr. Mukhtar Ahmad Masoodi (July 2014 – June 2015)

Cross-Sectional observational study to establish the relationship between neutrophil to lymphocyte ratio (NLR) Disease activity score (DAS), Health Assessment Questionnaire (HAQ) and short form 36 (SF36) in patients of Rheumatoid Arthritis.

 

 

Dr. Shijoy. K. S (Batch: June 2012 – May 2013)

The outcome of pregnancies in women with Antiphospholipid Antibody Syndrome

 

 

 

Clinical Trial Projects

S.NO

Clinical Trial Projects Title

Year

Study Period

Recruitment 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

RA

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 YEARS

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

3 YEARS

CLOSED

RA

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

3 YEARS

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

3 YEARS

CLOSED

RA

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

3 YEARS

CLOSED

RA

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 YEARS

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

3 YEARS

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

3 YEARS

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

3 YEARS

CLOSED

RA

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

RA

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 YEAR

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

RA

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

2010 APPROVED

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 BE APPROVED

RA

 

 

 

Clinical Trial Details

 

Sl. No.

Protocol Title

Year of Initiation

Year of Completion

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

2012

RA

2

 

A Randomized, Open label, Four Arms Parallel Study to Evaluate the Safety and Efficacy of Anti-CD6 Monoclonal Antibody (T1h mAb) in Combination with Methotrexate in Patients with Active Rheumatoid Arthritis

 

 

2007

2010

RA

3

 

Double-blind, triple dummy, parallel-group, randomized, six month study to compare Celecoxib (200 mg BID) with diclofenac SR (75 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 No A3191084" from the sponsor company Pfizer Limited

 

 

2007

2009

OA & RA

4

 

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

 

 

 

 

 

2008

2015

RA

Sl. No.

Protocol Title

Year of Initiation

Year of Completion

Study On

5

 

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

2010

RA

6

 

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

2010

RA

7

 

A Phase IIA, Randomized, Double Blind, Placebo-Controlled, Multicener 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

 

 

2009

2010

RA

8

 

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

 

2009

2011

OA

9

 

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

 

 

2010

2011

GOUT

Sl. No.

Protocol Title

Year of Initiation

Year of Completion

Study On

10

 

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

 

 

2009

2011

GOUT

11

 

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

 

 

 

 

2009

 

 

 

 

2011

RA

12

 

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of CP-690,550 Monotherapy in Patients with Active Rheumatoid Arthritis

 

2009

2010

RA

13

 

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

 

2010

2012

RA

14

 

A Long-Term, Open-Label Follow-Up Study Of Tasocitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

 

2012

2012

RA

15

 

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

 

 

 

2010

2011

RA

Sl. No.

Protocol Title

Year of Initiation

Year of Completion

Study On

16

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) (Phase 3b Protocol No. P06129)

 

2010

2012

RA

17

A Randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or two anti-TNF therapies"

2011

2015

 

RA

 

18

 

A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2)

 

 

2012

2015

SLE

19

 

A Phase IIb, 12 week Randomized, Double-Blind, Parallel Group, Placebo-Controlled study to evaluate Efficacy, Safety and Tolerability of 2, 4 and 6 mg of Revamilast in patients with Active Rheumatoid Arthritis who have had an inadequate response to Methotrexate

2012

2013

RA

20

A phase 2b, Dose ranging study to evaluate the efficacy and safety of Sifalimumab in adults with systemic lupus erythematosus

2012

2014

SLE

Sl. No.

Protocol Title

Year of Initiation

Year of Completion

Study On

21

 

A phase 3 double blind, randomized, placebo-controlled, safety and efficacy study of once daily controlled release Pregabalin in the treatment of patients with fibromyalgia (Protocol A0081245)

 

2011

2012

Fibromyalgia

22

 

A Randomized, double-blind, placebo-controlled, multicentre, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX Therapy

 

2012

2014

RA

23

 

Efficacy & Safety of Hydoxychloroquine and Methotrexate Combination in Treatment of Juvenile Rheumatoid Arthritis: A Double Blind, Randomized Comparison with Methotrexate Alone

 

2012

2014

RA (Juvenile)

24

 

A phase 3, Randomized, Double-blind, Active comparator study of the Efficacy and safety of R-TPR-015 (1422015) in patients with Active Rheumatoid Arthritis on stable dose of Methotrexate

 

 

2012

2014

RA

25

A Randomized Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis

 

 

2014

2015

RA

26

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs

2014

2015

RA

Sl. No.

Protocol Title

Year of Initiation

Year of Completion

Study On

27

 

A double-blind, randomized, parallel group study comparing pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity of three anti-CD2O monoclonal antibodies in subjects with moderate to severe active, seropositive rheumatoid arthritis with an inadequate response to methotrexate based therapy

 

2014

2018

RA

28

 

Prospective, multi-center, randomized, double-blind, two-arm, parallel group, active-control, comparative clinical study to evaluate efficacy and safety of R-TPR-021/Humira in Patients with Active Rheumatoid Arthritis on a stable dose of Methotrexate

 

2014

2014

RA

29

 

A randomized, double-blind, multi-center, phase 3 study to compare the efficacy and safety of BMO-2 (adalimumab) and Humira® (adalimumab) in patients with active Rheumatoid Arthritis

 

2016

2018

RA

30

 

A Randomized, Double-blind, Placebo and active-controlled, Multicenter, Phase 3 study to assess the efficacy and safety of Filgotinib administered for 52 weeks in combination with methotrexate to subjects with moderately to severely Active Rheumatoid Arthritis who have an inadequate response to methotrexate.

 

2017

2019

RA

31

 

A Randomized, Double-blind, Placebo and active-controlled, Multicenter, Phase 3 study to assess the efficacy and safety of Filgotinib administered for 52 weeks alone and in combination with Methotrexate (MTX)to subjects with moderately to severely Active Rheumatoid Arthritis who are Naïve to MTX Therapy

 

 

2016

2019 

RA

Sl. No.

Protocol Title

Year of Initiation

Year of Completion

Study On

32

 

A phase 2 dose-range finding 12-week, double blind, randomized, parallel group study to evaluate safety and efficacy of GRC 27864 in patients with moderate to severe osteoarthritis pain.

 

 

2018

Ongoing

OA

33

 

A Multicentre, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis.

 

2019

Ongoing

RA

34

 

An open label, prospective, post marketing study to evaluate the safety, tolerability and efficacy of rituximab with glucocorticoids in adult patients with Wegener's Granulomatosis or Microscopic Polyangiitis.

 

 

2018

Ongoing

Wegener's Granulomatosis or Microscopic Polyangiitis.

35

 

Randomized, controlled open label clinical study to compare the impact of single transition from Enbrel Auto-Injector (AI) to YLB113 AI on safety, PK and Compare usability of both AIs in patients with active rheumatoid arthritis (RA)

 

 

2019

Ongoing

RA

36

 

A randomized, double-blind, placebo-controlled, parallel-group, phase 3 study of baricitinib in patients with systemic lupus erythematosus (SLE).

 

 

2019

Ongoing

SLE

37

 

A phase-IV, Multicenter, noncomparative, open-label study evaluation the safety and efficacy of Golimumab (a fully human Anti-TNFa Monoclonal antibody, administered subcutaneously) in the treatment of Indian patients with active spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis.

2019

Ongoing

AS or PA