None listed
Conditions
Interventions
Group 1 Type of group
After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive intravenous (IV) golimumab at a dose of 2 mg/kg once monthly for a period of 6 months or until remission is achieved. Participants will receive IV GLM at a dose of 2 mg/kg at the start of Month 7, and then at the start of Month 8 and Month 10 if the subject has not achieved remission at any of these IV administration visits. If remission is achieved, participants were switch
After 6 months of treatment in study Part 1, participants with good or moderate response but not in remission will receive subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months, in combination with background DMARD treatment.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Each subject must be willing and able to provide written informed consent for the trial. • Each subject must be =18 years of age. A subject may be of either sex, or any race/ethnicity. • Each subject must have a diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria. • Each subject must have active disease (DAS28-ESR =?3.2) despite DMARD treatment. • 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. • 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. • Each subject must be able to adhere to dose and visit schedules. • 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.
Exclusion criteria
Exclusion criteria: • A subject must not have a history of biologic drug use for RA. • A subject must not have evidence of active TB or latent TB that is untreated. • 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. • A subject must not have a history of moderate to severe heart failure (NYHA class III/IV) even if medically controlled. • 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. • 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. • 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. • A subject must not have allergy/sensitivity to investigational product(s) or its/their excipients, including latex. • A female subject must not be breast-feeding. • A female subject must not be pregnant or intending to become pregnant. • 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. • A subject must not be participating in any other interventional clinical trial. • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease >1.2 units and a final DAS28-ESR 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR <= 5.1 units Measure:Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6 Timepoints:Month 6 ; Outcome name:The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. Measure:Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12 Timepoints:Start of Month 11, End of Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low = 10 to =15 mg/week). A total of 28 joints were evaluated. Measure:Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6 Timepoints:Baseline, Month 2, Month 4, Month 6 ; Outcome name:The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only. Measure:Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6 Timepoints:Baseline, Month 2, Month 4, Month 6 ; Outcome name:The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated. Measure:Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6 Timepoints:Baseline, Month 2, Month 4, Month 6 ; Outcome name:The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Measure:Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6 Timepoints:Baseline, Month 2, Month 4, | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungaria, Israel, Italy, Korea South, Mexico, Monaco, Netherlands, Norway, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kindgdom
Contacts
Public ContactFrancisco Orbegozo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed