FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2009/091/000596 [Registered on: 29/07/2009]
Last Modified On: 14/03/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis  
Scientific Title of Study
Modification(s)  
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 
Secondary IDs if Any  
Secondary ID  Identifier 
A3921045  Protocol Number 
NCT00814307  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Swapnali Raut 
Designation  Compliance Oversight Lead 
Affiliation  Representing Pfizer Limited 
Address  Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400 102
India 
Phone  91-9821415224  
Fax  91-22-26525993  
Email  Swapnali.raut@pfizer.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Swapnali Raut 
Designation  Compliance Oversight Lead 
Affiliation  Representing Pfizer Limited 
Address  Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400 102
India 
Phone  91-9821415224  
Fax  91-22-26525993  
Email  Swapnali.raut@pfizer.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Swapnali Raut 
Designation  Compliance Oversight Lead 
Affiliation  Representing Pfizer Limited 
Address  Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400 102
India 
Phone  91-9821415224  
Fax  91-22-26525993  
Email  Swapnali.raut@pfizer.com  
 
Source of Monetary or Material Support  
Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102 India  
 
Primary Sponsor
Modification(s)  
Name  Pfizer Limited  
Address  Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
NIL  Nil 
 
Countries of Recruitment     Brazil
Bulgaria
Chile
Colombia
Czech Republic
Dominican Republic
Germany
India
Malaysia
Mexico
Philippines
Poland
Russian Federation
Ukraine
United States of America  
Sites of Study
Modification(s)  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Arvind Chopra  Arthritis Research and Care Foundation Center for Rheumatic Diseases  No. 11, Hermes Elegance,1988, Convent Street Camp-411 001
Pune
MAHARASHTRA 
020-26345624, 09822009140
020-26334756
crdp@vsnl.net 
Dr. Manoj Kumar Venkataiya Honnakere  Bowring and Lady Curzon Hospitals  Shivaji Nagar, ,-560 001
Bangalore
KARNATAKA 
080-25581212, 09844021930
080-25581212
orthomanoj@gmail.com 
Dr. Srikantiah Chandrashekara  Chanre Rheumatology & Immunology Center & Research  #149, 15th Main, NHCL, Water Tank Road, 4th Block, 3rd Stage, ,Basaveswaranagar,-560 079
Bangalore
KARNATAKA 
080-23368030, 09845041151
080-23368029
chanrericr@yahoo.co.in;chandrashekara_s@yahoo.com 
Dr. Jacob Chacko  Father Muller Medical College  Fr. Muller Road,Kankanady,,-575 002
Bangalore
KARNATAKA 
0824-2238000, 09845081423
0824-2433301
chackojakes@yahoo.co.in 
Dr. Shrikant Wagh  Jehangir Clinical Development Centre Pvt. Ltd.  Jehangir Hospital, 32, Sassoon Road, ,-411 001
Pune
MAHARASHTRA 
020-26059318, 9822032373
020-26059319
sywagh@yahoo.co.in 
Dr. Prabha Adhikari   Kasturba Medical College Hospital  Attavar,-575 001
Bangalore
KARNATAKA 
0824-2445858, 9880991290
0824-2425092
adhikari_pmr@yahoo.com 
Dr Sarath Chandra Mouli Veeravalli  Krishna Institute of Medical Sciences Ltd.  1-8-31/1, Minister Road,,-500003

 
040 ? 27725153, 09866000685
040 ? 27840980
sarath10@hotmail.com 
Dr Jugal Kishore Kadel  Mahavir Hospital and Research Center   10-1-1, Bhagwan Mahavir Marg,A.C. Guards, ,-500 004
Hyderabad
ANDHRA PRADESH 
09246544284, 040-23497392
040-23320447
jkishorek71@yahoo.co.in 
Dr. Vikram I. Shah  Shalby Hospitals  Opp.Karnavati Club,,S.G.Road, P.O. Ambavadi Vistar -380054
Ahmadabad
GUJARAT 
079-40203000
079-40203115
Research1@shalby.org 
Dr. Uppuluri Ramakrishna Rao  Sri Deepti Rheumatology Centre  6-2-45/8, A. C. Guards,-500004
Hyderabad
ANDHRA PRADESH 
040-23395684,9849160640
040-23379432
urkrao@yahoo.com 
Dr. Vineeta Shobha   St John's Medical College Hospital,   Sarjapur Road, ,-560 034
Bangalore
KARNATAKA 
080-22065354, 09342534554
080-2553 0070
vineeta_shobha@yahoo.co.in; immunology_clinical_trials@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
CRD Ethics Committee  Approved 
Ethics Committee Bangalore Medical College & Research Institute  Approved 
Ethics Committee Shalby Hospitals  Approved 
Ethics Committee, Sri Deepti Rheumatology Centre  Approved 
FR. Muller Charitable Institutions Ethics Committee   Approved 
Hirabai Cowasji Jehangir Medical Research Institute and Jehangir Clinical Development Center Ethics Committee  Approved 
Institutional Ethical Committee for Bio Medical Research Bhagwan Mahavir Medical Research Center  Approved 
Institutional Ethics Committee for 10. Dr. Srikantiah Chandrashekara  Approved 
Institutional Ethics Committee for 9. Dr Sarath Chandra Mouli Veeravalli  Approved 
Institutional Ethics Review Board  Approved 
Manipal University Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Arthritis, Rheumatoid 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  NILL  NILL 
Intervention  Sequence 1: Active 5mg- Experimental Intervention: Drug: CP-690,550   Drug: CP-690,550 5mg CP-690,550 BID PO for 6 months  
Intervention  Sequence 2: Active 10 mg- Experimental   Drug: CP-690,550 10 mg CP-690,550 BID PO for 6 months  
Intervention  Sequence 3: Placebo Comparator   Drug: Placebo Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit  
Intervention  Sequence 4: Placebo Comparator   Drug: Placebo Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a. Ages Eligible for Study:18 Years and older,
b. Genders Eligible for Study:Both,
c. Accepts Healthy Volunteers:No,
1. The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
2. The patient has active disease at both Screening and Baseline, as defined by both greaterthan equal to 6 joints tender or painful on motion; and greaterthan equal to 6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) greaterthan equal to 28 mm in the local laboratory. 2. CRP greaterthan 7 mg/L in the central laboratory
3. Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
4. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
5. Patient has washed out of all DMARDs other that antimalarials
There is no upper age limit for inclusion criteria for this trial 
 
ExclusionCriteria 
Details  -Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L -History of any other autoimmune rheumatic disease other than Sjogren's syndrome -No malignancy or history of malignancy. ?History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1. American College of Rheumatology 20 (ACR20) responder rate versus placebo
2. Change from baseline in the Health Assessment Questionnaire (HAQ DI)
3.Compare the rate of achieving DAS28DAS28 4(ESR) lessthan 2.6 with placebo  
3 months  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Incidence and severity of adverse events   All time points (at each scheduled visit at which the data was collected. Not all measures were performed at every scheduled visit) 
ACR20 responder rates  All time points (at each scheduled visit at which the data was collected. Not all measures were performed at every scheduled visit) 
ACR50 responder rates   All time points (at each scheduled visit at which the data was collected. Not all measures were performed at every scheduled visit) 
ACR70 responder rates   All time points (at each scheduled visit at which the data was collected. Not all measures were performed at every scheduled visit) 
DAS 28   All time points (at each scheduled visit at which the data was collected. Not all measures were performed at every scheduled visit) 
HAQ-DI   All time points (at each scheduled visit at which the data was collected. Not all measures were performed at every scheduled visit) 
SF-36   Months 1 ,3, 6 and early termination  
Incidence and severity of clinical laboratory abnormalities   All time points (at each scheduled visit at which the data was collected. Not all measures were performed at every scheduled visit) 
Summary of changes in physical examination compared to baseline by subject   All time points (at each scheduled visit at which the data was collected. Not all measures were performed at every scheduled visit) 
Mean change from baseline in vital signs (blood pressure, heart rate, and oral, temporal or tympanic temperature preferred) measurements   All time points (at each scheduled visit at which the data was collected. Not all measures were performed at every scheduled visit)
 
MOS Sleep scale   Months 1 ,3,6 and early termination  
FACIT Fatigue scale   Months 1 ,3,6 and early termination  
Euro Qol EQ 5D scale   Months 1 ,3,6 and early termination  
RA Healthcare Resource Utilization Questionnaire   Months 1 ,3,6 and early termination 
Work Limitations Questionnaire   Months 1 ,3,6 and early termination 
Number of Days required for a >1 day CONSECUTIVE sequential decrease in: - Patient Assessment of Arthritis Pain; - Patient Global Assessment of Arthritis.  2 weeks  
 
Target Sample Size
Modification(s)  
Total Sample Size="500"
Sample Size from India="100" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  
24/08/2009 
Date of First Enrollment (Global)  09/02/2009 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NONE 
Brief Summary
Modification(s)  

The study is a Phase 3 randomized, 6-month, double-blind, placebo-controlled, parallel group Study, to compare the efficacy of CP-690,550, as Monotherapy, in doses of 5 mg BID and 10 mg BID versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA), in subjects with RA who have had an inadequate response to a DMARD (traditional or biologic), as measured by ACR20 response rates at Month 3.

The site close out date in India is 27 Aug 2010.  

 

 
Close