None listed
Conditions
Interventions
This group will be treated with Golimumab at a dose of 2 mg / kg at week 0 and at week 12. Subsequently, and depending on the clinical response, an additional dose of Golimumab of 2 mg / kg will be applied at week 16 and another of 4 mg / kg in week 24 and every 12 weeks from this point, at least until completing 48 weeks. During this period, methotrexate will be received at stable doses and frequency, defined specifically for each patient.
Group name:GROUP V Type of group
This group will be treated with Golimumab Placebo, IV at week 0 and at week 12. Subsequently, and depending on the clinical response, a dose of Golimumab of 4 mg / kg will be applied at week 16 and another dose of 4 mg / kg at week 24 and every 12 weeks from this point, at least until completing 48 weeks. During this period Methotrexate will be received in stable doses and frequency, defined specifically for each patient.
Sponsors
CENTOCOR RESEARCH & DEVELOPMENT INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female 18 years of age or older. 2. Diagnosis of AR performed at least 3 months before the selection. 3. Have received treatment with MTX at a dose of at least 15 mg / week for at least 3 months before selection, and have received a stable dose of MTX> 15 mg / week and <25 mg / week at least 4 weeks before the selection. 4. Present active AR. 5. If the subject receives NSAIDs or other analgesics for RA, they must have taken a stable dose for at least 2 weeks before the first administration of the study drug. 6. If the subject is receiving oral corticosteroids, they should have taken a stable dose equivalent to <10 mg of prednisone / day for at least 2 weeks before the first administration of the study drug. 7. Women and men with the potential to procreate should be using an adequate contraceptive method during the study and for 6 months after receiving the last dose. 8. Subjects considered candidates according to the following criteria for evaluating TB: a) They have no history of latent or active TB before selection. b) They do not present signs or symptoms that suggest active TB in the clinical history and / or in the physical examination. c) They have not had recent close contact with a person with active TB. d) Within the month prior to the first administration of the study drug, they must present negative results in the diagnostic tests of TB. e) They present a chest X-ray taken within 3 months prior to the first administration of the study drug and interpreted by a qualified radiologist, without evidence of current active TB or previous inactive TBC. 9. The results of laboratory analysis in the selection must meet the following criteria: a) Hemoglobin ≥ 8.5 g / dL. b) Leukocyte count ≥ 3.5 x 10-3 cells / uL. c) Neutrophils ≥ 1.5 x 10-3 cells / uL. d) Platelets ≥ 100 x 10-3 cells / uL. e) ALT and serum AST levels that do not exceed 1.5 times the upper limit of normal. f) Serum creatinine that does not exceed 1.5 mg / dL. 10. Subjects who wish and are able to comply with the program of study visits and other requirements of the protocol. 11. Subjects capable of giving informed consent, which must be obtained before carrying out any procedure related to the study.
Exclusion criteria
Exclusion criteria: 1. Subjects presenting other inflammatory diseases. 2. Subjects who received treatment with DMARD during the 4 weeks prior to the first administration of the study drug. 3. Subjects who received corticosteroids intra-articularly, intramuscularly or IV, including adrenocorticotrophic hormone, during the 4 weeks prior to the first administration of the study drug. 4. Subjects that have a confirmed hypersensitivity to human immunoglobulin proteins or other components of golimumab. 5. Subjects who have presented a clinically serious adverse reaction to a biological anti-TNFα agent. 6. Subjects who received infliximab in the 3 months prior to the first administration of the study drug. 7. Subjects who received etanercept or adalimumab in the 2 months prior to the first administration of the study drug. 8. Subjects who received rituximab or abatacept. 9. Subjects who received natalizumab or other agents directed to integrin-4-alpha. 10. Subjects who received anakinra during the 4 weeks prior to the first administration of the study drug. 11. Subjects who received alefacept or efalizumab in the 3 months prior to the first administration of the study drug. 12. Subjects who have used cytotoxic agents. 13. Subjects who received any drug under study, within the 5 half lives of said drug before the first administration of the study drug. 14. Pregnant women, breastfeeding women or men or women who plan pregnancies within 6 months after receiving the last administration of the study drug. 15. Subjects with a history of latent or active granulomatous infection. 16. Subjects who received a vaccine with Bacillus Calmette-Guerin (BCG) in the 12 months prior to selection. 17. Subjects with a chest x-ray within 3 months prior to the first administration of the study drug that shows an abnormality that suggests malignancy or active current infection. 18. Subjects who have had a non-tuberculous mycobacterial infection or opportunistic infection. 19. Subjects who received or will receive a live or bacterial virus vaccine within 3 months prior to the first administration of the study drug, during the study or within 6 months after the last administration of the study drug. 20. Subjects with a history of joint prosthesis infected or who received antibiotics for suspected joint prosthesis infection, if the prosthesis was not removed or replaced. 21. Subjects who presented a serious infection, were hospitalized for an infection or received intravenous antibiotic treatment for an infection during the 2 months prior to the first administration of the study drug. 22. Subjects with a history or presence of a chronic or recurrent infectious disease. 23. Subjects with infection confirmed by human immunodeficiency virus (HIV), hepatitis B or hepatitis C. 24. Subjects with a confirmed history of demyelinating disease. 25. Subjects with current signs or symptoms of renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric or severe cerebral disease, progressive or uncontrolled. 26. Subjects with a history or presence of congestive heart failure (CHF). 27. Subjects with a history of lymphoproliferative disease. 28. Subjects with any confirmed current malignancy or history of malignancy within the previous 5 years. 29. Subjects with a history of organ transplantation. 30. Subjects with a history of subs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The ACR (American College of Rheumatology) answer is the numerical edition of the improvement of the multiple criteria of evaluation of the disease. It is defined as an improvement ≥ 50% from the baseline evaluation in: 1) Counting of inflamed joints (66 joints) and sore joint count (68 joints) AND 2) Improvement ≥ 50% in 3 of the following 5 evaluations: a) Assessment of pain by the patient. b) Overall evaluation of the activity of the disease by the patient. c) Overall assessment of the activity of the disease by the doctor. d) Evaluation of the physical function by the patient. e) C-reactive protein. Measure:Answer ACR 50 in week 14. Timepoints:Week 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1 and 2: According to the ACR criteria (previously detailed) and adjusted to 50% and 20%. Criterion 3: Disease Activity Index Score 28 (DAS-28) using PCR, is a statistically derived index that combines aching joints (28 joints), inflamed joints (28 joints), CRP, and overall activity evaluation of the disease by the patient (GH). Criterion 4: Health questionnaire - 36-item abbreviated form (SF-36), assesses the quality of life of the subject, consists of 8 scales of multiple items: limitations of physical functioning, limitations of usual activities due to physical problems, body pain , general mental health, limitations of usual activities due to personal or emotional problems, limitations of social functioning due to physical or mental health problems, vitality and general perception of health. Measure:Main secondary criteria: 1) ACR 50 response in Week 24. 2) ACR 20 response in Week 14. 3) Response according to DAS 28 using PCR in Week 14. 4) Change from the basal evaluation in the physical component score of the SF-36 in Week 14. Timepoints:ACR 50: Week 24. ACR 20, DAS 28 and SF-36: Week 14. ; Outcome name:Criteria 1-3: According to the ACR criteria (previously detailed) and adjusted to 20%, 50% and 70%. The values ​​of the erythrocyte sedimentation rate (ESR) will be added. Criteria 4-7: According to the score of the Activity Index of Disease 28 (DAS-28), previously detailed. The values ​​of the erythrocyte sedimentation rate (ESR) and the PCR will be added. Criterion 8: Disability index of the health assessment questionnaire (HAQ), is a questionnaire of 20 questions, which assesses the degree of difficulty a person has in performing tasks in 8 functional areas (dressing, getting up, eating, walking , hygiene, reaching objects, grabbing objects and activities of daily life). Criterion 9: Health questionnaire - 36 item abbreviated form (SF-36), previously detailed. Measure:Ef | — |
Countries
Argentina, Australia, Belgium, Colombia, Germany, Hungary, Latovia, Lithuania, Malasya, MAlta, Mexico, New Zealand, Poland, Russian Federation, Ukraine, United States
Outcome results
None listed