Toxicological evaluation of the humanized Anti-CD6 MAb T1h in Rheumatoid Arthritis Patients

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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)

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 Alberto Reyes Llerena M.D., PhD.,2nd degree of specialist in Rheumatology

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

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

Intervention(s):

Four level of dosis of humanized Anti-CD6 MAb T1h Level 1: 0.2 mg/Kg Level 2: 0.4 mg/Kg Level 3: 0.8 mg/Kg, and Level 4: 1.6 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.

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:

19

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:

Rodriguez

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana city

País:

Cuba

Zip Code:

CP 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:

Rodriguez

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana city

País:

Cuba

Zip Code:

CP 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:

2008-08-01 20:00

Link to the spanish version:

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Toxicological evaluation of the humanized Anti-CD6 MAb T1h in Rheumatoid Arthritis Patients

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