| CTRI Number |
CTRI/2011/091/000575 [Registered on: 12/01/2011] |
| 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
|
This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate. |
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 In Patients With Active Rheumatoid Arthritis On Background Methotrexate |
| Trial Acronym |
ORAL SCAN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A3921044 |
Protocol Number |
| NCT00847613 |
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
400102
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
400102
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
400102
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)
|
|
|
Countries of Recruitment
|
India
Australia
Brazil
Bulgaria
Canada
Colombia
Czech Republic
Greece
Japan
Mexico
Other
Poland
Republic of Korea
Ukraine
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Arvind Chopra |
Center for Rheumatic Diseases |
11, Hermes Elegance, 1988, Convent ST. Camp. ,-411001
Pune
MAHARASHTRA |
20-26345624/26348529, 09822009140
20-26334756
crdp@vsnl.net |
| 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 - 23235599, 65623023
080 - 23238080
chandrashekara_s@yahoo.com; chanrericr@yahoo.co.in |
| Dr. Shrikant Wagh Y |
Jehangir Clinical Development Centre Pvt. Ltd. |
Jehangir Hospital Premises,32, Sassoon Road-411001
Pune
MAHARASHTRA |
20-26059319, +919822032373
20-26059318
sywagh@yahoo.co.in; neeta@jcdc.co.in |
| Dr. Sarath Chandra Mouli Veeravalli |
Krishna Institute of Medical Sciences |
1-8-31/1, Minister Road,,-500003
|
040-27725153, 9866000685
040-27840773
Sarath10@hotmail.com, ravineela@gmail.com |
| Dr Jugalkishore Kadel |
Mahaveer Hospital and Research Center |
Department of Rheumatology,A.C. Guards-500001
Hyderabad
ANDHRA PRADESH |
040-23497392
040-23320447
jkishorek71@yahoo.co.in |
| Dr. Uppuluri Ramakrishna Rao |
Sri Deepti Rheumatology Centre |
6-2-45/8, A.C.Guards,-500004
Hyderabad
ANDHRA PRADESH |
040-23395684
040-23379432
urkrao@yahoo.com; firdaus674@yahoo.com |
| Dr. Vineeta Shobha |
St.Johns Medical College Hospital |
Sarjpur Road,-560034
Bangalore
KARNATAKA |
080-22065354
080 - 25503697
vineeta_shobha@yahoo.co.in;immunology_clinical_trials@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| CRD Ethics Committee |
Approved |
| Ethics CommitteeSri Deepti Rheumatology |
Approved |
| Hirabai Cowasji Jehangir Medical Research Institute |
Approved |
| Institutional Ethical Committee for Bio Medical Research |
Approved |
| Institutional Ethical Review Board, St. Johns Medical College |
Approved |
| Institutional Ethics Committee Krishna Institute of Medical sciences |
Approved |
| Institutional Ethics Committee, Bangalore |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Arthritis, Rheumatoid, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Sequence 1: Drug: CP-690,550 (5 mg BID) and
Drug: CP-690,550 (5 mg BID)
|
Drug: CP-690,550 Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. (Other Name: Double-blind, placebo-controlled period)
Drug: CP-690,550 Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period. (Other Name: Double-blind, Active Extension Period)
|
| Intervention |
Sequence 2: Drug: CP-690,550 (10 mg BID) and
Drug: CP-690,550 (10 mg BID)
|
Drug: CP-690,550
Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. (Other Name: Double-blind, placebo-controlled period)
Drug: CP-690,550
Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.Other Name: Double-blind, Active Extension Period)
|
| Comparator Agent |
Sequence 3: Drug: Placebo and Drug: CP-690,550 (5 mg BID) |
Drug: Placebo
Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. (Other Name: Double-blind, placebo-controlled period)
Drug: CP-690,550
Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.
(Other Name: Double-blind, Active Extension Period) |
| Comparator Agent |
Sequence 4: Drug: Placebo and Drug: CP-690,550 (10 mg BID) |
Drug: CP-690,550
Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.(Other Name: Double-blind, Active Extension Period )
Drug: Placebo
Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
(Other Name: Double-blind, placebo-controlled period) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Ages Eligible for Study: 18 Years and older
2.Genders Eligible for Study: Both
3.Accepts Healthy Volunteers: No
4.Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate
There is no upper age limit for inclusion criteria for this trial |
|
| ExclusionCriteria |
| Details |
Pregnancy, severe or unstable medical conditions, including serious infections (e.g., tuberculosis, HIV), clinically significant laboratory abnormalities (transaminases, hemoglobin), or use of prohibited concomitant medications (all DMARDs except methotrexate). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To compare the efficacy of 2 doses of CP-690,550 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis as measured by ACR 20 response rates. |
6 months.
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To compare the efficacy of 2 doses of CP-690,550 versus placebo measured by ACR20, ACR 50, ACR70 and DAS 28 response rates |
2 years |
| To compare the durability of ACR20, ACR50, and ACR70 and DAS 28 response rates. |
2 years |
| To investigate possible associations between genomic and metabolomic variation in relation to interventions in an optional supplement requiring separate consent not required for participation in primary study |
2 years |
| To compare effects on all health outcomes measures in the study at each visit, as appropriate for the specific outcome, compared to baseline. |
2 years |
|
Target Sample Size
Modification(s)
|
Total Sample Size="750"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
11/08/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/03/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A total of 100 subjects from India will be included in the study. |