| CTRI Number |
CTRI/2012/05/002688 [Registered on: 24/05/2012] Trial Registered Prospectively |
| Last Modified On: |
28/05/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Safety Extension Trial for Subjects with Systemic Lupus Erythematosus. |
|
Scientific Title of Study
|
An Open-label Long-term Safety Extension Trial for Subjects with Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 011,826 |
Other |
| AN-SLE3322 Final 22 Feb 2011 |
Protocol Number |
| NCT01305746 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Garg |
| Designation |
Senior Manager- Clinical Operations |
| Affiliation |
Kendle India Pvt Ltd |
| Address |
Unit No-002, Ground Floor, Tower C, Cyber Park, Sector 39
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4536300 |
| Fax |
|
| Email |
sgarg@incresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Singh |
| Designation |
Senior Manager- Regulatory Affairs |
| Affiliation |
Kendle India Pvt Ltd |
| Address |
Unit No-002, Ground Floor, Tower C, Cyber Park, Sector 39
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4536300 |
| Fax |
|
| Email |
masingh@incresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Singh |
| Designation |
Senior Manager- Regulatory Affairs |
| Affiliation |
|
| Address |
Kendle India Pvt Ltd,
Unit No-002, Ground Floor, Tower C, Cyber Park, Sector 39
HARYANA
122001
India |
| Phone |
0124-4536300 |
| Fax |
|
| Email |
masingh@incresearch.com |
|
|
Source of Monetary or Material Support
|
| Anthera Pharmaceuticals, Inc. |
|
|
Primary Sponsor
|
| Name |
Anthera Pharmaceuticals Inc |
| Address |
25801 Industrial Boulevard, Suite B
Hayward, CA 94545
U.S.A. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kendle India Pvt ltd |
Unit No-002, ground Floor, Tower C, Cyber Park, Sector 39, Gurgaon-122001 |
|
|
Countries of Recruitment
|
Argentina
Brazil
Chile
Colombia
Hong Kong
India
Mexico
Peru
Philippines
Taiwan
United States of America |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mathew Thomas |
Health and Research Centre |
T.C. 1/907, 1st
Floor, Devi Scans Building, Kumarapuram
Medical College P.O., Trivandrum - 695011,, Kerala
Thiruvananthapuram
KERALA |
0471-2554911
healthtrials@gmail.com |
| Dr Sarath C Veeravalli |
Krishna Institute of Medical Sciences, Department of Rheumatology |
1-8-31/1, Minister Road, Hyderabad - 500003, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH |
040-44885153
sarath10@hotmail.com |
| Dr Vineeta Shobha |
St. John Medical College Hospital |
Department of Medicine, Sarjapura Road, Koramangala, Bangalore - 560034, Karnataka, India
Bangalore
KARNATAKA |
080-22065354
vineeta_shobha@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Independent Human Ethics Committee,Trivandrum,Dr.Mathew Thomas |
Approved |
| Institutional Ethical Review Board, St. Johns Medical College |
Submittted/Under Review |
| Institutional Ethics committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
SLE, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
A-623 |
-A-623 200 mg subcutaneous (SC) weekly
- A-623 100 mg SC weekly
- A-623 200 mg SC every 4 weeks
Duration of Treatment:Until A-623 is approved for clinical use in SLE or the Sponsor discontinues the study. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Completed the treatment period specified in study AN-SLE3321 |
|
| ExclusionCriteria |
| Details |
1. Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures.
a) This includes active significant infection, malignancy, and acutely life or organ-threatening manifestation of SLE (e.g., proliferative nephritis or unstable CNS lupus).
2. Females who are nursing, pregnant, or intending to become pregnant during the time of the study, or who have a positive pregnancy test at baseline (if the subject is a female of childbearing potential). Males who are intending to impregnate a female. All sexually-active subjects of reproductive potential are required to use a reliable method of birth control during the study and for 3 months following completion of therapy. A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom) or vasectomy.
3. Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods
a) Cyclophosphamide or other alkylating agent – 3 months prior to screening
b) Cyclosporine – 2 months prior to screening
c) Anti-TNF alpha – 3 months prior to screening
d) Transfusion, IV immunoglobulin, plasmapheresis or plasma exchange – 3 months prior to screening
e) Live vaccines – 30 days prior to screening
4. Any prior administration of a B-cell modulating therapy (i.e., belimumab, TACI-Ig, epratuzumab, rituximab) other than A-623.
5. General
a) Subject has known sensitivity to any of the products to be administered during dosing.
b) Subject will not be available for follow-up assessment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-The primary objective of the study is to assess the safety of A-623 following long-term
administration. |
long-term treatment i.e 52 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary objective in the study |
None |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="51"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/05/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/05/2011 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a multi-center, open-label long-term extension study to assess the safety of A-623 in subjects with serologically active SLE who have completed studyAN-SLE3321. The study will be conducted in approximately 90 centers worldwide. Up to 600 subjects will be eligible to enroll into the study if they complete the AN-SLE3321 study. In order to preserve the blind on study AN-SLE3321 through its completion, subjects who received A-623 in the double-blind study AN-SLE3321 will continue treatment with the same dose of A-623 (200 mg subcutaneous [SC] weekly, 100 mg SC weekly, or 200 mg SC every 4 weeks). Subjects who received placebo will now receive A-623 at a dose corresponding to the treatment arm to which they were randomized in the doubleblind study AN-SLE3321. Subjects will receive study drug starting on Day 0 and then either weekly (100 mg and 200 mg dose groups) or every 4 weeks (200 mg dose group). Safety will be monitored throughout the study, with study visits at Week 4, 8, 16, and then every 12 weeks thereafter. Subjects who discontinue study drug or withdraw from the study will be followed for an additional 8 weeks for additional clinical and safety evaluations. This is a multi-center, open-label long-term extension study to assess the safety of A-623 in subjects with serologically active SLE who have completed study AN-SLE3321. The study will be conducted in approximately 90 centers worldwide. Up to 600 subjects will be eligible to enroll into the study if they complete the AN-SLE3321 study. In order to preserve the blind on study AN-SLE3321 through its completion, subjects who received A-623 in the double-blind study AN-SLE3321 will continue treatment with the same dose of A-623 (200 mg subcutaneous [SC] weekly, 100 mg SC weekly, or 200 mg SC every 4 weeks). Subjects who received placebo will now receive A-623 at a dose corresponding to the treatment arm to which they were randomized in the doubleblind study AN-SLE3321. Subjects will receive study drug starting on Day 0 and then either weekly (100 mg and 200 mg dose groups) or every 4 weeks (200 mg dose group). Safety will be monitored throughout the study, with study visits at Week 4, 8, 16, and then every 12 weeks thereafter. Subjects who discontinue study drug or withdraw from the study will be followed for an additional 8 weeks for additional clinical and safety evaluations. |