Estudio múlticéntrico, aleatorio, doble ciego, controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFalfa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa tratados previamente con agentes biológicos anti-TNFalfa.
- Conditions
- Active rheumatoid arthritis (RA)Artritis Reumatoide activa
- Registration Number
- EUCTR2005-001742-16-ES
- Lead Sponsor
- Centocor B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
1. Are women or men 18 years of age or older.
2. Have a diagnosis of RA (according to the revised 1987 criteria of the ARA; Arnett et al, 1988) for at least 3 months prior to screening.
3. Have active RA as defined in this study by persistent disease activity with at least 4 swollen and 4 tender joints at the time of screening and at baseline.
4. Must have previously received at least 1 dose of etanercept, adalimumab, or infliximab.
5. If currently using MTX, sulfasalazine and/or hydroxychloroquine, must have tolerated these medications for at least 12 weeks prior to the first administration of study agent and be on a stable dose for at least 4 weeks prior to the first administration of study agent.
6. If using NSAIDs or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent.
7. If using oral corticosteroids, must be on a stable dose equivalent to equal to or less than 10 mg of prednisone/day for at least 2 weeks prior to the first administration of study agent. If currently not using corticosteroids, the subject must have not received oral corticosteroids for at least 2 weeks prior to the first administration of study agent.
8. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study and for 6 months after receiving the last administration of study agent. Female subjects of childbearing potential must test negative for pregnancy.
9. Are considered eligible according to the following TB screening criteria:
a. Have no history of latent or active TB prior to screening.
b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.
d. Within 1 month prior to the first administration of study agent, either have negative diagnostic TB test results, or have a newly identified positive diagnostic TB test result (defined as either a positive tuberculin skin test or a positive QuantiFERON-TB Gold test) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent.
e. Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.
10. Have screening laboratory test result as follows:
a. Hemoglobin equal to or more than 8.5 g/dL (International System of Units [SI]: equal to or more than 85 g/L) or equal to or more than 5.3 mmol/L.
b. WBC equal to or more than 3.5 x 10^3 cells/microL (SI: equal to or more than 3.5 x 10^9 cells/L).
c. Neutrophils equal to or more than 1.5 x 10^3 cells/microL (SI: equal to or more than 1.5 x 10^9 cells/L).
d. Platelets equal to or more than 100 x 10^3 cells/microL (SI: equal to or more than 100 x 10^9 cells/L).
e. Serum ALT and AST levels not exceeding 1.5 times the ULN for the central laboratory con
1. Have other inflammatory diseases, including but not limited to PsA, AS, systemic lupus erythematosus, or Lyme disease, that might confound the evaluation of the benefit of golimumab therapy.
2. Have been treated with DMARDs/systemic immunosuppressives other than MTX, sulfasalazine, or hydroxychloroquine (eg, leflunomide, azathioprine, cyclosporine, mycophenolate mofetil) during the 4 weeks prior to the first administration of study agent.
3. Have received intra-articular, IM, or IV corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to the first administration of study agent.
4. Have a known hypersensitivity to human immunoglobulin proteins or other components of the golimumab.
5. Have had a clinically serious adverse reaction to a biologic anti-TNFalfa agent.
6. Have received infliximab within 12 weeks prior to the first administration of the study agent.
7. Have received adalimumab or etanercept within 8 weeks prior to the first administration of the study agent.
8. Have received natalizumab or rituximab.
9. Have received anakinra during the 4 weeks prior to the first administration of study agent.
10. Have received alefacept or efalizumab within the 3 months prior to the first administration of the study agent.
11. Have used cytotoxic agents, including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents.
12. Have received any investigational anti-TNFalfa agent including but not limited to golimumab, CDP870, lenercept, or onercept.
13. Have been treated with any investigational drug (other than an anti-TNFalfa agent) within 5 half-lives of that drug prior to the first administration of study agent.
14. Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of the study agent.
15. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
16. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
17. Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB.
18. Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months prior to screening.
19. Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months prior to the first administration of study agent, during the trial, or within 6 months after the last administration of study agent.
20. Have a history of an infected joint prosthesis, or have received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
21. Have had a serious infection (eg, hepatitis, pneumonia, or pyelonephritis), have been hospitalized for an infection, or have been treated with IV antibiotics for an infection within 2 months prior to the first administration of study agent. Less serious infections (eg, acute upper respiratory tract infection, simple UTI) need not be considered exclusionary at the discretion of the investigator.
22. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis, recurrent UTI (eg, recurrent pyelonephritis, chronic nonremitting
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the efficacy of golimumab in subjects with active RA who have been previously treated with biologic anti-TNFa agent(s) by assessing reduction in signs and symptoms of RA at Week 14.;Secondary Objective: to assess the safety, physical function, pharmacodynamics, and population pharmacokinetics of golimumab in subjects with active RA who have been previously treated with biologic anti-TNFa agent(s).;Primary end point(s): American College of Rheumatology (ACR) 20 response at Week 14
- Secondary Outcome Measures
Name Time Method