Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

April 9, 2015 updated by: Janssen Biotech, Inc.

A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (ENBREL) or Adalimumab (HUMIRA)

The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching participants from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of a main study and a voluntary, open-label (participants and researchers are aware about the treatment participants are receiving), 24-week study extension. The main study includes a Screening Run-in Period (Week -6 to Week 0), an Open-label Treatment Period (Week 0 to Week 16), an Open-label or Double-blind Treatment Period (Week 16 to Week 52). The main study also includes a Follow-up Period from Week 52 through Week 64 for those participants who will not participate in the 24-week study extension. Participants, participating in 24-week extension (at Week 52), will receive open-label golimumab SC injections every 4 weeks from Week 52 up to Week 72 and will be followed-up up to Week 88. All eligible participants will initiate the treatment with open-label golimumab SC injection every 4 weeks up to Week 12. At Week 16, depending upon the treatment response either participants will continue to receive open-label golimumab SC injection every 4 weeks up to Week 48 or participants will be randomly assigned to receive following 2 treatments: 1- golimumab 50mg SC injection every 4 weeks along with placebo intravenous infusion every 8 weeks through Week 48; 2- Placebo SC injection every 4 weeks along with golimumab 2mg/kg intravenous infusion every 8 weeks through Week 48. At Week 52, participants who choose to participate in the 24-week study extension will receive open-label golimumab 50 mg SC injections every 4 weeks through Week 72. Participants' safety will be monitored throughout the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
433

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
  • Belgium
      • Brussel, Belgium
      • Genk, Belgium
      • Gent, Belgium
      • Liège, Belgium
      • Merksem, Belgium
  • Canada
      • Quebec, Canada
      • St Johns, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Hamilton, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Germany
      • Hamburg, Germany
      • Herne, Germany
      • München, Germany
      • Ratingen, Germany
  • Greece
      • Heraklion- Crete, Greece
      • Thessalonikis, Greece
  • Sweden
      • Stockholm, Sweden
  • United Kingdom
      • Cannock, United Kingdom
      • Leeds, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Merseyside, United Kingdom
      • Newcastle Upon Tyne, United Kingdom
      • Wigan, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Huntsville, Alabama, United States
      • Tuscaloosa, Alabama, United States
    • Arizona
      • Mesa, Arizona, United States
      • Phoenix, Arizona, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Covina, California, United States
      • Hemet, California, United States
      • Loma Linda, California, United States
      • Long Beach, California, United States
      • Murrieta, California, United States
      • Santa Maria, California, United States
      • Santa Monica, California, United States
      • Torrance, California, United States
      • Van Nuys, California, United States
      • Victorville, California, United States
      • Whittier, California, United States
    • Connecticut
      • Bridgeport, Connecticut, United States
      • Hamden, Connecticut, United States
      • Trumbull, Connecticut, United States
    • Florida
      • Aventura, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Jacksonville, Florida, United States
      • Naples, Florida, United States
      • Orange Park, Florida, United States
      • Orlando, Florida, United States
      • Palm Harbor, Florida, United States
      • Plantation, Florida, United States
      • Sarasota, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Duluth, Georgia, United States
    • Idaho
      • Coeur D'Alene, Idaho, United States
      • Idaho Falls, Idaho, United States
    • Illinois
      • Rockford, Illinois, United States
    • Indiana
      • South Bend, Indiana, United States
    • Iowa
      • Bettendorf, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Bowling Green, Kentucky, United States
    • Louisiana
      • Monroe, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Wheaton, Maryland, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Mississippi
      • Flowood, Mississippi, United States
      • Tupelo, Mississippi, United States
    • Missouri
      • Clayton, Missouri, United States
      • Florissant, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New Jersey
      • Freehold, New Jersey, United States
    • New York
      • Brooklyn, New York, United States
      • Mineola, New York, United States
      • Plainview, New York, United States
      • Rochester, New York, United States
      • Smithtown, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Greenville, North Carolina, United States
      • Hickory, North Carolina, United States
      • Wilmington, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Columbus, Ohio, United States
      • Mayfield, Ohio, United States
      • Middleburg Heights, Ohio, United States
    • Oklahoma
      • Edmond, Oklahoma, United States
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Lake Oswego, Oregon, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
      • Wexford, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • Myrtle Beach, South Carolina, United States
    • Tennessee
      • Hixson, Tennessee, United States
      • Jackson, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Carrollton, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Arlington, Virginia, United States
      • Chesapeake, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Spokane, Washington, United States
    • West Virginia
      • Beckley, West Virginia, United States
      • Clarksburg, West Virginia, United States
    • Wisconsin
      • Glendale, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have inadequate RA disease control prior to the first administration of study agent despite treatment with etanercept (Enbrel) + methotrexate or adalimumab (Humira) + methotrexate (MTX)
  • Must have received a stable dose of MTX greater than or equal to (>=) 7.5 milligram (mg) per week to less than or equal to (<=) 25 mg per week for at least 4 consecutive weeks prior to the first screening visit and must plan to maintain that dose throughout the study
  • Participants must have received etanercept or adalimumab in combination with MTX for a minimum of 3 months prior to the first visit
  • Negative tuberculosis (TB) test
  • Are capable of providing informed consent, which must be obtained prior to any study-related procedures

Exclusion Criteria:

  • Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, or are frequently in contact with individuals who carry active TB infection
  • Have inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, primary Sjogren's or Lyme disease
  • Have demonstrated a discernible improvement in disease activity between screening and prior to the first golimumab injection at Week 0
  • Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence)
  • Have a history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX
All enrolled and dosed participants receive golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 0 to Week 12.
Drug: Golimumab 50 mg SC
Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.
Drug: Methotrexate (MTX)
Participants will continue taking their current Methotrexate (MTX) treatment regimen.
Experimental: Double blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX
Participants, who do not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, will be randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
Drug: Golimumab 50 mg SC
Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.
Drug: Methotrexate (MTX)
Participants will continue taking their current Methotrexate (MTX) treatment regimen.
Drug: Placebo IV
Placebo matched to golimumab intravenous infusion every 8 weeks.
Experimental: DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
Participants, who do not achieve DAS28 good response at Week 16, will be randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
Drug: Methotrexate (MTX)
Participants will continue taking their current Methotrexate (MTX) treatment regimen.
Drug: Golimumab 2 mg/kg IV
Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks.
Drug: Placebo SC
Placebo matched to golimumab SC injection every 4 weeks.
Experimental: OL Group 1: Golimumab 50 mg SC + MTX
Participants, who achieve DAS28 good response at Week 16, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48.
Drug: Golimumab 50 mg SC
Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.
Drug: Methotrexate (MTX)
Participants will continue taking their current Methotrexate (MTX) treatment regimen.
Experimental: OL Study Extension Group: Golimumab 50 mg SC + MTX
Participants who complete the main study (Week 0 to Week 52), do not meet lack of efficacy criteria, and participate in the OL study extension, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
Drug: Golimumab 50 mg SC
Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.
Drug: Methotrexate (MTX)
Participants will continue taking their current Methotrexate (MTX) treatment regimen.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14
Time Frame: Week 14
Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
Week 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2
Time Frame: Within 2 weeks of initiating therapy
Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
Within 2 weeks of initiating therapy
Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52
Time Frame: Week 52
Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (<=) 3.2 at a given visit and improvement from Baseline was >1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, is reported.
Week 52
Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16
Time Frame: Week 52
Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, is reported.
Week 52
Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16
Time Frame: Week 76
Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, is reported.
Week 76
Change in ESR-based DAS28 Score at Week 76 Relative to Week 52
Time Frame: Week 52, 76
Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESR-based DAS28 score range: 0 to 9.4, higher score=more disease activity.
Week 52, 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Biotech, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR016663
  • CNTO148ART3002 (Other Identifier: Janssen Biotech Inc.)
  • 2009-010582-23 (EudraCT Number)
  • GO SAVE (Other Identifier: Janssen Biotech Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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