Evaluation of Safety and Efficacy of T1h (anti-CD6) as Monotherapy and in Combination with Methotrexate in Patientes with Rheumatoid Arthritis

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:

Secondary indentifying numbers:

IIC RD-EC098

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology Cuban Health Ministry

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 :

03/11/2007

Reference number:

3054/06.016.07B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Roberto

Last name:

Torres Moya

Medical Specialty :

MD. 2nd Degree Specialist in Rheumatology

Affiliation:

Surgical Clinical Hospital "10 de Octubre",

Postal address:

Calzada 10 de octubre No. 130 e/. Alejandro Ramírez y Agua Dulce

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-76442456

Email address:

torresg@infomed.sld.cu [1]

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, Surgical Clinical Hospital “Hermanos Ameijeiras”, Araceli Chico Capote, MD, second degree specialist in Rheumatology

Havana, Surgical Clinical Hospital “Manuel Fajardo”, Reinaldo Acosta Hernández, MD, second degree specialist in Rheumatology

Havana, Center of Medical and Surgical Research, Gil Reyes Llerena, MD, second degree specialist in Rheumatology

Santiago de Cuba, Province Hospital “Saturnino Lora”, Ricardo Moracen Cuevas, MD, second degree specialist in Rheumatology

Research ethics committees:

Surgical Clinical Hospital "10 de Octubre", June 20, 2007

Surgical Clinical Hospital “Hermanos Ameijeiras”, October 4, 2010

Surgical Clinical Hospital “Manuel Fajardo”, March 26, 2011

Center of Medical and Surgical Research, June 7, 2011

Province Hospital “Saturnino Lora”, September 6, 2011

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Suspended

Date of first enrollment:

14/01/2008

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

Health condition keyword:

Intervention(s):

Stage I: Four level doses of T1h (0.1, 0.2, 0.4 y 0.8 mg/Kg respectively) by Intravenous route [IV] (infusion in 200 mL of sterile 0.9% sodium chloride solution over 2 hours) once weekly for 12 weeks. Stage II: Group control: Placebo Group study: T1h at optimal dose determined in Stage I Both groups will receive the product (placebo or T1h) by intravenous route (detailed above), once weekly for 12 weeks. All patients will also receive concomitant MTX (7.5 to 25 mg/Kg orally), once weekly for 12 weeks.

Intervention code:

Antibodies, Monoclonal, Humanized

Methotrexate

Antibodies, Monoclonal

Antigens, CD

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):

Stage I: Safety, tolerability and optimal biological dose. Measuring time: 4th week after last T1h dose. Stage II: ACR50. Measuring time: 12nd week after last T1h dose.

Key secondary outcomes:

Pharmacokinetics, ACR20, ACR50, ACR 70. Measuring time: during 24 weeks of study

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:

65 years

Inclusion criteria:

1. Patients who expressed in writing in its informed consent form available from participating in the clinical trial. 2. Age between 18 and 65, inclusive, of any gender or skin color. 3. Patient who has not previously been treated with monoclonal antibodies. 4. Patients with at least 1 year with active RA diagnosed according to ACR criteria (American College of Rheumatology) revised in 1987. 5. Patients without concomitant anti-rheumatic during the four weeks before the administration of MAb. 6. Patients with hemoglobin = 8.5 g / L, WBC> 3x109 cells / mL, platelet count> 100x109/mL and transaminase (TGP) within the normal reference values (UI). 7. Patients with 8 or more joints swollen at the time of starting treatment. 8. Patients with 8 or more joints painful at the time of starting treatment.

Exclusion criteria:

1. Suffering from severe chronic concomitant Central Nervous System, Respiratory, cardiovascular, gastrointestinal tract or genitourinary system. 2. Suffering from any malignancy. 3. Suffering from an acute infection at the time of inclusion. 4. Suffering from a chronic infection. 5. Any Hematopoietic system disorder (congenital or acquired). 6. Suffering from other autoimmune rheumatic diseases that affect osteomioarticular system. 7. Pregnancy, childbirth and / or breastfeeding. 8. Patients who refuse to use contraception during the study. 9. Patients with intellectual or psychological dysfunction that not allow to understand and compliance with study requirements, according to the Principal Investigator.

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:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Other

Other design:

Phase I/II in two sequential steps: Step I: Multi-dose Ranging study. Step II: Randomized, Placebo-controlled, Double blind, Two arms, Parallel group study.

Phase:

1-2

Target sample size:

20 (stage I) 80 (stage II)

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:

Patricia

Last Name:

Hernández Casaña

Specialty:

PhD, Clinical Researcher Promoter

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 2143145

Email :

patriciahc@cim.sld.cu [2]

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:

Patricia

Last Name:

Hernandez Casana

Specialty:

PhD, Clinical Researcher Promoter

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

537-2143145

Email :

patriciahc@cim.sld.cu [2]

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:

RPCEC00000035

Date of Registration in Primary Registry:

2010-12-27

Record Verification Date:

2013/11/07

Next update date:

2014/11/07

Link to the spanish version:

Click here [3]