Supplemental Material 1: Inclusion/Exclusion Criteria
Supplemental Material 1: Inclusion/Exclusion Criteria
| |Inclusion Criteria- To be eligible for the study, subjects must have met all of the following criteria: |
|1. |Were women or men of 18 years of age or older. |
|2. |Had 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. |Must have been treated with and tolerated MTX at a dose of at least 15mg/week for at least 3 months prior to screening |
| |and had a MTX dose of ≥15 mg/week and ≤25 mg/week and stable for at least 4 weeks prior to screening |
|4. |Had active RA as defined, for the purpose of this study, by persistent disease activity with at least 4 swollen and 4 |
| |tender join, at the time of screening and at baseline and at least 2 of the following 4 criteria: |
| a. |CRP ≥ 1.5 mg/dL at screening or ESR by Westergren method of ≥ 28 mm in the first hour at screening or baseline. |
| b. |Morning stiffness of ≥ 30 minutes at screening and baseline. |
| c. |Bone erosion by x-ray and/or by MRI prior to the first administration of study agent. |
| d. |Anti-cyclic citrullinated peptide (anti-CCP) antibody positive or RF-positive at screening. |
|5. |If using NSAIDS or other analgesics for RA, must have been on a stable dose for at least 2 weeks prior to the first |
| |administration of the study agent. |
|6. |If using oral corticosteroids, must have been on a stable dose equivalent to a ≤ 10mg 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 the first administration of study agent. |
|7. |Women of child bearing potential or men capable of fathering children must have been 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. |
|8. |Were considered eligible according to the following TB screening criteria: |
| a. |Had no history of latent or active TB prior to screening. |
| b. |Had no signs or symptoms suggestive of active TB upon medical history and/or physical examination. |
| c. |Had no recent close contact with a person with active TB or, if there had been such contact, were to 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, either have had diagnostic TB test results (defined as|
| |both a negative tuberculin skin test and a negative QuantiFERON-TB Gold test, as outlined in Appendix A and Appendix B,|
| |respectively) or have had 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 had been ruled out and|
| |for which appropriate treatment for latent TB had been initiated either prior to or simultaneously with the first |
| |administration of study agent. |
|9. |Had screening laboratory test result as follows: |
| a. |Hemoglobin ≥ 8.5 g/dL (International System of Units [SI]: ≥ 85g/L) or ≥5.3 mmol/L. |
| b. |WBC ≥ 3.5x103 cells/μL (SI: ≥ 3.5 x 109 cells/L). |
| c. |Neutrophils ≥ 1.5 x 103 cells/ μL (SI: ≥ 1.5 x 109 cells/L). |
| d. |Platelets ≥ 100 x 103 cells/ μL (SI: ≥ 100 x 109 cells/L). |
| e. |Serum alanine aminotransferase and aspartate aminotransferase levels not exceeding 1.5 times the ULN for the central |
| |laboratory conducting the test. |
| f. |Serum creatinine not exceeding 1.5 mg/DL (SI: ≤ 133 μmol/L). |
|10. |Were willing and able to adhere to the study visit schedule and other protocol requirements. |
|11. |Were capable of providing informed consent, which must be obtained prior to any study-related proceedings. |
| |Exclusion Criteria- Subjects who met any of the following criteria were not enrolled in the study: |
|1. |Had inflammatory disease other than RA, including but not limited to PsA, AS, systemic lupus erythematosus, or Lyme |
| |disease, that might have confounded the evaluation of the benefit of golimumab therapy. |
|2. |Had been treated with DMARDs/systemic immunosuppressives (eg, D-penicillamine, hydroxychloroquine, oral or parenteral |
| |gold, sulfasalazine, lefunomide, azathioprine, cyclosporine, mycophenolate mofetil) other than MTX during the 4 weeks |
| |prior to first administration of study agent. |
|3. |Had received intra-articular, IM, or IV corticosteroids, including adrenocorticotropic hormone, during the 4 weeks |
| |prior to first administration of the study agent. |
|4. |Had a known hypersensitivity to human immunoglobulin proteins or other components of golimumab. |
|5. |Had received infliximab, etanercept, adalimumab, rituximab, or natalizumab. |
|6. |Had received anakinra during the 4 weeks prior to first administration of study agent. |
|7. |Had received alefacept or efalizumab within 3 months prior to the first administration of the study agent. |
|8. |Had used cytotoxic agents, including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents. |
|9. |Had been treated with any intervestigational drug, including golimumab, within 5 half-lives of that drug prior to the |
| |first administration of the study agent. |
|10. |Were pregnant, nursing, or planning a pregnancy or fathering a child within six months after receiving the last |
| |administration of study agent. |
|11. |Had a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidiomycosis. |
|12. |Had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening. |
|13. |Had 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. |
|14. |Had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, |
| |aspergillosis) within 6 months prior to screening. |
|15. |Had 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. |
|16. |Had a history of infected joint prosthesis, or had received antibiotics for a suspected infection of a joint |
| |prosthesis, if that prosthesis has not been removed or replaced |
|17. |Had a serious infection (eg, hepatitis, pneumonia, pyelonephritis, or sepsis), had been hospitalized for an infection, |
| |or had 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 urinary tract infection) may not have been|
| |considered exclusionary at the discretion of the investigator. |
|18. |Had 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 urinary tract infection (eg, recurrent |
| |pyelonephritis, chronic nonremitting cystitis), an open, draining, or infected skin wound or ulcer. |
|19. |Were known to be infected with HIV, hepatitis B, or hepatitis C. |
|20. |Had a history of known demyelinating diseases such as multiple sclerosis or optic neuritis. |
|21. |Had current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, |
| |endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease. |
|22. |Had a history of, or concurrent, CHF, including medically controlled, asymptomatic CHF |
|23. |Had a history of lymphoprolifeative disease, including lymphoma, or signs suggestive of possible lymphoproliferative |
| |disease such as lymphadenopathy of unusual size or location, or clinically significant splenomegaly. |
|24. |Had any known malignancy or had a history of malignancy within the previous 5 years (with the exception of a |
| |nonmelonoma skin cancer that has been treated with no evidence of recurrence). |
|25. |Had a transplanted organ (with the exception of a corneal transplant performed >3 months prior to first study agent |
| |administration |
|26. |Had a substance abuse (drug or alcohol) problem within the previous 3 years. |
|27. |Were unwilling or unable to undergo multiple venipunctures because of poor tolerability or lack of easy access. |
|28. |Were participating in another trial with an investigational agent or procedure. |
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