E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to evaluate the efficacy of SC injections of golimumab in subjects with active PsA by assessing reduction in signs and symptoms of PsA and inhibition of progression structural damage. |
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E.2.2 | Secondary objectives of the trial |
to evaluate the efficacy of golimumab in: 1) achieving sustained arthritis response, 2) improving psoriatic skin lesions, 3) improving physical function, and 4) improving quality of life; and to assess the safety of golimumab in subjects with active PsA. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Are women or men 18 years of age or older. 2. Have PsA that was diagnosed at least 6 months prior to the first administration of study agent. 3. Have active PsA at the time of screening and at baseline, as characterized by 3 or more swollen joints and 3 or more tender joints. 4. Have at least 1 of the PsA subsets: DIP joint arthritis, polyarticular arthritis with the absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis. 5. Have active plaque psoriasis with a qualifying target lesion equal to or greater than 2 cm in diameter, but not on axilla, inframammary area, or groin. 6. Are negative for RF according to the reference range of the central laboratory conducting the test. 7. Have active arthritis despite current or previous DMARD or NSAID therapy. DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4 weeks. 8. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures 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 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. If using MTX, should have started treatment at least 3 months prior to the first administration of study agent and should have no serious toxic side effects attributable to MTX. MTX routes of administration and doses (not to exceed 25 mg/week) should be stable for at least 4 weeks prior to the first administration of the study agent. If currently not using MTX, must have not received MTX for at least 4 weeks prior to the first administration of the study agent. 11. If using NSAIDs, must be on a stable dose for at least 2 weeks prior to the first administration of study agent. If currently not using NSAIDS, must not have received NSAIDs for at least 2 weeks prior to the first administration of the study agent. 12. 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, must have not received oral corticosteroids for at least 2 weeks prior to the baseline visit. Reference is made to the protocol for a complete overview (MISSING ITEMS 13 - 17). |
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E.4 | Principal exclusion criteria |
1. Have other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy, including but not limited to RA, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease. 2. Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of study agent. 3. Have received any systemic immunosuppressives within 4 weeks prior to the first administration of study agent. 4. Have received DMARDs other than MTX or anakinra within 4 weeks prior to the first administration of study agent. 5. Have received leflunomide within 4 weeks prior to the first administration of study agent, or have received leflunomide within 3 months prior to the first administration of study agent and have not undergone a drug elimination procedure. 6. Have received intra-articular, IM, or IV corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to the first administration of study agent. 7. Have used alefacept or efalizumab within 3 months prior to the first administration of study agent. 8. Have used any biologic agents that are targeted for reducing TNFalfa, including but not limited to infliximab, etanercept, and adalimumab. 9. Have used rituximab or natalizumab. 10. Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab. 11. Have used cytotoxic drugs, including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents. 12. Have been treated with any investigational drug within 5 half-lives of that drug prior to the first administration of study agent. 13. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening. 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 within 6 months prior to screening. 17. Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study agent, during the trial, 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 or 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. 20. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, an open, draining, or infected skin wound, or an ulcer. 21. Are known to be infected with HIV, hepatitis B, or hepatitis C. 22. Have a history of known demyelinating diseases such as multiple sclerosis or optic neuritis. 23. Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease. 24. Have a history of, or concurrent, CHF, including medically controlled, asymptomatic CHF. 25. Have a history of lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location, or clinically significant splenomegaly. 26. Have any known malignancy or have a history of malignancy within the previous 5 years. 27. Have a transplanted organ. Reference is made to the protocol for a complete overview (MISSING ITEMS 28-30).
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E.5 End points |
E.5.1 | Primary end point(s) |
the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response at Week 14, and the change from baseline in total radiographic scores of the hands and feet at Week 24. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 2 |