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Toxicological evaluation of the humanized Anti-CD6 MAb T1h in Rheumatoid Arthritis Patients
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Toxicological evaluation of the humanized Anti-CD6 MAb T1h in Rheumatoid Arthritis Patients
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Toxicological evaluation of the humanized Anti-CD6 MAb T1h in Rheumatoid Arthritis Patients. Clinical Trial phase I.
Secondary indentifying numbers:
IIC RD-063
Issuing authority of the secondary identifying numbers:
Center of Molecular Immunology (CIM)
Primary sponsor:
Center of Molecular Immunology (CIM)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Government funds
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of the Quality of Drugs(CECMED)
Authorization date :
09/05/2003
Reference number:
326/05.019.02B
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Gil
Midle name:
Alberto
Last name:
Reyes Llerena
Medical Specialty :
2nd degree of specialist in Rheumatology
Affiliation:
Center of Researches Surgical-Medical (CIMEQ)
Postal address:
Calle 216 y 11-B, Reparto Siboney
City:
Havana
Country:
Cuba
Zip Code:
11600
Telephone:
+53-78581000
Email address:
email@not.entered
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Havana City, National Service of Rheumatology of Clinical and Surgical Teaching Hospital "10 de Octubre", Roberto Torres Moya, MD. 2nd degree specialist in Rheumatology
Research ethics committees:
Center of Researches Surgical-Medical (CIMEQ), October 18, 2002.
Clinical and Surgical Teaching Hospital "10 de Octubre", February 2th, 2004.
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
30/07/2004
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Rheumatoid Arthritis
Health condition(s) code:
Arthritis, Rheumatoid
Arthritis
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Autoimmune System Diseases
Intervention(s):
Four level of dosis of humanized Anti-CD6 MAb T1h Level 1: 0.1 mg/Kg Level 2: 0.2 mg/Kg Level 3: 0.4 mg/Kg, and Level 4: 0.8 mg/Kg It begins in the lower level. Each patient receives a total of 6 administrations of MAb by intravenously route once a week for 6 weeks.
Intervention code:
Antibodies, Monoclonal, Humanized
Antigens, CD
Antibodies, Monoclonal
Administration, Intravenous
Intervention keyword:
T1h (anti-CD6)
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Security of T1h in the maximum dose level, expressed as no incidence of severe adverse events, no immunogenicity and no signs of opportunistic infections. Expression of ACR20. Measuring Time: 1st and 4th weeks after the last dose of T1h.
Key secondary outcomes:
Expression of ACR50. Measuring Time: 1st and 4th weeks after the last dose of T1h.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
18 years
Maximum age:
69 years
Inclusion criteria:
1. Patients who expressed in writing in its informed consent form their willingness to participate in the clinical trial. 2. Age over 18 and under 70 annos annos, of either sex or race. 3. Patient who has not previously been treated with monoclonal antibodies. 4. Patients without concomitant anti-rheumatic during the four weeks before the administration of MAb and until 4 weeks after completing the administration of the last dose of mAb (only able to receive the paracetamol as a painkiller). 5. Patients with hemoglobin> 10 g / L, WBC> 3x109 cells / mL, platelet count> 100x109/mL and transaminase (GPT) within the normal reference values (UI).
Exclusion criteria:
1. Functional class IV according to Steinbrocker's criteria 2. Intercurrent infection. 3. Concomitant severe chronic disease (lung, heart, liver or kidney). 4. Pregnancy, childbirth and/or breastfeeding. 5. Female patients of childbearing age who do not have a negative pregnancy diagnosis and / or refuses to use an IUD as contraceptive method for as long as the extension of the study. 6. Patients who not meet the inclusion criteria. 7. Patients with history of severe allergies. 8. Patients with psychological dysfunction, intellectual or sensory impairment, that not allow to understand and compliance with study requirements according to criteria of the Principal Investigator. 9. Patients with any type of malignancy desease
Type of population:
Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
N/A: single arm study
Masking:
Open
Control group:
Uncontrolled
Study design:
Single group
Phase:
1
Target sample size:
15
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Pedro
Middle Name:
Camilo
Last Name:
Rodríguez Rodríguez
Specialty:
1st Grade Specialist in Pharmacology
Affiliation:
Center of Molecular Immunology (CIM)
Postal Address:
Calle 216 Esquina 15, Atabey, Playa
City:
Havana
Country:
Cuba
Zip Code:
16040, Box11600
Telephone:
(537) 271-79-33 ext 224
Email :
camilo@cim.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Pedro
Middle Name:
Camilo
Last Name:
Rodríguez Rodríguez
Specialty:
1st Grade Specialist in Pharmacology
Affiliation:
Center of Molecular Immunology (CIM)
Postal Address:
Calle 216 Esquina 15, Atabey, Playa
City:
Havana city
Country:
Cuba
Zip Code:
16040, Box11600
Telephone:
(537) 271-79-33 ext224
Email :
camilo@cim.sld.cu
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000007
Date of Registration in Primary Registry:
2010-12-24
Record Verification Date:
2017/01/20
Next update date:
2018/01/20
Link to the spanish version:
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