An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroids
- Conditions
- Rheumatoid arthritis (RA)Therapeutic area: Diseases [C] - Immune System Diseases [C20]MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
- Registration Number
- EUCTR2008-006064-11-LT
- Lead Sponsor
- Janssen Biologics B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 564
To be eligible for the study, subjects must meet all of the following criteria:
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 been treated with and tolerated MTX at a dose of at least 15 mg/week for at least 3 months prior to screening, and have been on a stable MTX dose of = 15 mg/week and = 25 mg/week for at least 4 weeks prior to screening.
4. Have active RA, as defined by persistent disease activity with at least 6 swollen and 6 tender joints, at the time of screening and at baseline.
5. CRP = 1.0 mg/dL at screening.
6. Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF)-positive at screening.
7. 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.
8. If using oral corticosteroids, must be on a stable dose equivalent to = 10 mg of prednisone/day for at least 2 weeks prior to 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 first administration of study agent.
9. 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.
10. 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 6 weeks prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result (Appendix A of the protocol), or have a newly identified positive QuantiFERON-TB Gold test result 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. Indeterminate results should be handled as outlined in Section 5.1 of the protocol. A negative tuberculin skin test (see Appendix B of the protocol) is additionally required if the QuantiFERON-TB Gold test is not approved/registered in that country.
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.
11. Have screening laboratory test result as follows:
a. Hemoglobin = 8.5 g/dL (International System of Units [SI]: = 85 g/L) or = 5.3 mmol/L.
b. WBCs = 3.5 × 103 cells/µL (SI: = 3.5 × 109 cells/L).
c. Neutrophils = 1.5 × 103 cells/µL (SI: = 1.5 × 109 cells/L).
d. Platelets = 100 × 103 cells/µL (SI: = 100 × 109 cells/L).
e. Serum A
Subjects meeting any of the following criteria may not be enrolled in the study:
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 (other than MTX)/systemic immunosuppressives (eg, D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate mofetil) during the 4 weeks prior to first administration of study agent.
3. Have received intra-articular, IM, or IV corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to first administration of study agent.
4. Have a known hypersensitivity to human Ig proteins or other components of golimumab.
5. Have ever received any commercial or investigational anti-TNF therapy such as but not exclusively infliximab, golimumab, adalimumab, certolizumab pegol, or etanercept.
6. Have received rituximab or efalizumab or abatacept.
7. Have received natalizumab or other agents that target alpha-4-integrin.
8. Have received anakinra during the 4 weeks prior to first administration of study agent.
9. Have received alefacept within the 3 months prior to the first administration of the study agent.
10. Have used cytotoxic agents, including but not limited to chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents.
11. Have been treated with any investigational drug, within 5 half-lives of that drug prior to the first administration of study agent.
12. Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of study agent.
13. Have a history of latent or active granulomatous infection, including histoplasmosis, or coccidioidomycosis prior to screening. Refer to inclusion criteria # 10 for information regarding eligibility with a history of latent TB.
14. Have had a bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
15. 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.
16. Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening. 17. 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 study, or within 6 months after the last administration of study agent.
18. 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.
19. 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 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.
20. Have a history of, or ongoing, chronic or recurrent (> 3 identical infections/12 months) infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method