Phase I with CIGB-814 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:

Safety and pharmacokinetics of CIGB-814 in patients with rheumatoid arthritis

Secondary indentifying numbers:

IG/CIGB-814/AR/1201/

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center of Genetic Engineering and Biotechnology (CIGB) Ministry of Public Health (MINSAP)

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 Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

08/05/2013

Reference number:

05-017-12-B

Principal investigator

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

First name:

Dinorah

Midle name:

Maria Isabel

Last name:

Prada Hernandez

Medical Specialty :

Second Degree Specialist in Rheumatology

Affiliation:

National Center for Rheumatology. Clinical Hospital “10 de Octubre”

Postal address:

Ave "10 de Octubre", No. 130

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-78776286

Email address:

cmolinero@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, Center for Surgical Medical Research, Alfredo Hernandez Martinez, MD. 2nd Degree Specialist in Rheumatology

Research ethics committees:

Clinical Hospital “10 de Octubre”, April 05, 2013

Center for Surgical Medical Research, May 02, 2013

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

25/03/2014

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

Joint Diseases

Rheumatic Diseases

Musculoskeletal Diseases

Connective Tissue Diseases

Skin and Connective Tissue Diseases

Autoimmune Diseases

Immune System Diseases

Intervention(s):

Group I (Experimental): CIGB-814, dose of 1 mg by subcutaneous route, once a week for the first four weeks and monthly the remaining five months of treatment. Group II (Experimental): CIGB-814, dose of 2.5 mg by subcutaneous route, once a week for the first four weeks and monthly the remaining five months of treatment. Group III (Experimental): CIGB-814, dose of 5 mg by subcutaneous route, once a week for the first four weeks and monthly the remaining five months of treatment.

Intervention code:

Peptides

Injections, Subcutaneous

Intervention keyword:

CIGB-814

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):

Severe Adverse Events (EA) with very probable / certain or probable causal relationship with product administration (serious / serious "seriousness" with "probable", "very likely / safe" causation). Measurement time: weekly (1st month) and months 2, 3, 4, 5, 6, 9 and 12.

Key secondary outcomes:

Relating to safety: Adverse Events-AE (Type of AE, description of AE), Time between time of administration and the occurrence of AE (hours and minutes or days), Duration of AE (date of onset and duration of AE in days or hours and (Severe / Serious or Non-Severe / Non-Severe), Intensity of AE (Mild, Moderate or Severe), Causal Relationship (Not Evaluable / Unclassifiable, Unrelated, unlikely, probable, likely, very likely / safe), Attitude followed by onset of AE (continuing or stopping treatment), EA treatment (according to AE intensity), AE outcome). Measurement time: weekly (1st month) and months 2, 3, 4, 5, 6, 9 and 12. Relating to Pharmacokinetics: Maximum concentration (Cmax), Time at which Cmax (Tmax) is reached, Average life time (T ½), Area under the curve (AUC). Measurement time: before starting the treatment, after the 1st dose at 30 min, at 1 hr, at 1 ½ hr, at 2 hrs, at 4 hrs, at 6 hrs, at 8 hrs, at 12 hrs, at 18 hrs and 24 hours. Relating to the effect: Clinical response according to ACR (ACR20, ACR50, ACR70) Measurement time: Week 28, Month 9, Month 12. Clinical response according to DAS28 (DAS28 <2.6), Disease activity (DAS28> 2.6 and DAS28 <= 3.2), Moderate disease activity (DAS28> 3.2 and DAS28 <= 5.2), Disease activity Severe (DAS28> 5.2)). Measuring time: Week 28, Month 9, Month 12. Sub lymphocyte populations (CD4 + CD25 + Foxp3 + by flow cytometry). Measuring time: 24 h Determination of cytokines (TNFα, IFNγ, TGFβ, IL-1, IL-2, IL-10 and IL-17). Measuring time: Week 28, Month 9, Month 12. Quality of life (Questionnaire SF-36). Measuring time: week 28, Month 9, Month 1

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

65 years

Inclusion criteria:

1. Patients diagnosed of rheumatoid arthritis active ≥ 2 years 2. Patients with moderate disease activity (DAS28) 3. Patients that did not respond to conventional treatment 4. Patients evaluated in ex vivo assays with CIGB-814 5. 19 ≤ Age < 65 6. Laboratory parameters within normal limits 7. Female patient of gestation age with negative pregnancy test and use effective contraceptive methods or male patient employing effective methods to prevent procreation. 8. Patient complimenting a previous period of washing, which ranged from 2 to 4 weeks, according to previous treatment with or without FARME 9. Personal interest express written by the patient enrolled in the study with his/her signature consent to participate.

Exclusion criteria:

1. Pregnancy, postpartum or breastfeeding. 2. Allergy to paracetamol. 3. Treatment with another investigational product at the time of inclusion. 4. Rheumatoid arthritis burned. 5. Complicated Rheumatoid arthritis 6. Other rheumatic autoimmune diseases affecting the osteomioarticular system. 7. Alcoholism. 8. Patient drug-dependent. 9. Concomitant Chronic Diseases 10. States due to severe febrile infectious or septic processes not associated with disease progression. 11. Hematologic disease. 12. Malignancy. 13. Congenital or acquired immune deficiency at the time of inclusion. 14. Psychological intellectual or sensory dysfunction that may impede understanding and compliance with the requirements of the study.

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:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

Dose escalation

Phase:

Target sample size:

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:

Dinorah

Middle Name:

Maria Isabel

Last Name:

Prada Hernandez

Specialty:

2nd Degree Specialist in Rheumatology

Affiliation:

National Center for Rheumatology. Clinical Hospital “10 de Octubre”

Postal Address:

Ave "10 de Octubre', No. 130

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-78776286

Email :

cmolinero@infomed.sld.cu [1]

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:

Maria

Middle Name:

del Carmen

Last Name:

Dominguez Horta

Specialty:

Doctor of Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

+53-72504387

Email :

mcarmen.dominguez@cigb.edu.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:

RPCEC00000238

Date of Registration in Primary Registry:

16/02/2017

Record Verification Date:

2017/02/16

Next update date:

2018/02/16

Link to the spanish version:

Click here [3]