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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 September 2012 |
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Main ID: |
EUCTR2009-011137-26-FI |
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Date of registration:
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25/08/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE |
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Date of first enrolment:
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22/10/2009 |
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Target sample size:
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3150 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011137-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Greece
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Hungary
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Ireland
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Italy
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Netherlands
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Poland
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Portugal
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Spain
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
The subject must fulfill ALL the criteria listed below for entry in Part 1:
1. Each subject must be willing and able to provide written informed consent for the trial.
2. Each subject must be =18 years of age. A subject may be of either sex, and any race/ethnicity.
3. Each subject must have a diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria.
4. Each subject must have active disease (DAS28-ESR =?3.2) despite DMARD treatment.
5. Each subject must still be taking at least one of the allowed DMARDs, at a stable dose for at least one month prior to trial entry, and must be considered capable of maintaining the stable dose during the trial.
6. Each subject must be eligible for anti-TNF use according to the following criteria:
a. Subject must have failed conventional treatment according to the investigator’s opinion OR local guidelines.
b. Local guidelines regarding safety screening of anti-TNF candidates (ie, tuberculosis [TB] screening, specific laboratory tests, and other safety screening such as vaccination, if applicable) must be met. Screening for latent TB must include a chest C-ray and either a skin test or QuantiFERON-Gold test.
c. The results of the anamnesis and physical examination must make the subject eligible for anti-TNF use and trial participation according to the investigator’s judgment.
7. Each subject must be able to adhere to dose and visit schedules.
8. Each female subject or male subject and his female sexual partner of childbearing potential must agree to use a medically accepted method of contraception prior to enrollment, while receiving protocol-specified medication and for 6 months after stopping the medication. Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), inert or coppercontaining IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation). Other methods may be used as required by local legislation. Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period.
The subject must fulfill ALL the criteria listed below for entry in Part 2:
1. Each subject must have been eligible for Part 1 and must have completed Part 1 of this trial.
2. Each subject must have:
a. good or moderate DAS28-ESR response to 6 months of SC-GLM50 regimen (ie, response at the end of Month 6 compared to Baseline), AND
b. no DAS28-ESR remission (ie, DAS28-ESR =?2.6) at the end of that period.
3. The trial site must have access to facilities that can perform IV infusions.
4. Both the investigator and the subject must agree to switch the subject’s treatment to IV administration as required for Arm 1 in Part 2 of this trial.
5. The investigator must judge that no safety events (eg, serious adverse events [SAEs], serious infections, marked injection-site reactions or intolerance to drug) have occurred that could reoccur or aggravate with increased drug exposure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
The subject must fulfill ALL the criteria listed below for entry in this trial.
1. A subject must not have a history of biologic drug use for RA.
2. A subject must not have evidence of active TB or latent TB that is untreated.
3. A subject must not have a history of lymphoproliferative disease or any unknown malignancy or history of malignancy within the previous 5 years, with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence.
4. A subject must not have a history of moderate to severe heart failure (NYHA class III/IV) even if medically controlled.
5. A subject must not have an inflammatory rheumatic disease other than RA that might confound the evaluations of safety and toxicity such as, but not limited to, ankylosing spondylitis and psoriatic arthritis.
6. A subject must not have any systemic inflammatory condition with signs and symptoms that might confound the evaluations of safety and toxicity from GLM therapy, including, but not limited to:
a. active Lyme disease,
b. systemic lupus erythematosus,
c. infectious or reactive arthritis,
d. Reiter’s syndrome,
e. nonrheumatoid vasculitis, or
f. parvovirus infection.
7. A subject must not have received any investigational drugs within the 30 days prior to Baseline, and must not receive them during the current trial.
8. A subject must not have allergy/sensitivity to investigational product(s) or its/their excipients, including latex.
9. A female subject must not be breast-feeding.
10. A female subject must not be pregnant or intending to become pregnant.
11. A subject must not have any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
12. A subject must not be participating in any other interventional clinical trial.
13. A subject must not be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Active Rheumatoid Arthritis
MedDRA version: 12.0
Level: LLT
Classification code 10039073
Term: Rheumatoid arthritis
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Intervention(s)
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Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: Golimumab
Product Code: SCH 900259
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Golimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
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Primary Outcome(s)
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Secondary Objective: Part 1: 1.Classify subjects by concomitant treatment and treatment history to investigate the following effect on secondary endpoints: concomitant MTX dose, non-MTX DMARD background, corticosteroids and the number of failed DMARDs. 2.Classify subjects by disease markers/characteristics to investigate effect of the following on efficacy endpoints: Baseline disease activity, chronicity, Baseline diagnostic serum markers. 3.Classify subjects by factors not disease/treatment-related to investigate the following effect on all efficacy endpoints: smoking, local guidelines/practices, subject expectations, MD experience/expectations. Part 2 (Compare the following): 1.AUC for DAS28 from end Month 6 to end Month 12 . 2.Time to DAS28-ESR remission between regimens. 3/4.Change in disease activity and subjects achieving low disease activity/remission measured by SDAI, DAS28 and subcomponents between regimens at every visit. 5.Patient-reported outcomes between regimens at every visit.
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Primary end point(s): Part 1: the proportion of subjects achieving DAS28-ESR EULAR response.
Part 2 coprimary efficacy endpoints:
1. Proportion of subjects who are in DAS28-ESR remission at the start of Month 11 (Visit 10).
2. Proportion of subjects who are in DAS28-ESR remission at the end of Month 12 (Visit 11).
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Main Objective: Part 1: Assess safety/efficacy of subcutaneous golimumab 50 mg (SC-GLM50), administered once monthly during 6 months, when combined with different DMARD regimens used in rheumatology practice. Subjects to be classified by concomitant treatment and treatment history to investigate the effect of the following factors on EULAR response assessed by the Disease Activity Score using the 28 tender and swollen joint count (DAS28): a. concomitant methotrexate (MTX) dose for subjects; b. concomitant DMARD backgrounds other than MTX; c. concomitant corticosteroids; d. number of failed DMARDs.
Part 2: Subjects who have responded to treatment in Part 1 (ie, from Baseline to end of Month 6) but have not achieved remission at the end of Month 6, to study whether a strategy of using intravenous GLM at 2 mg/kg body weight (IV-GLM2) to induce remission followed by SC-GLM50 to retain remission is superior to continuing a SC-GLM50 regimen.
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Secondary ID(s)
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2009-011137-26-DE
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P06129
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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