| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| 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 |
| The primary objective of this study is to evaluate the efficacy and safety of CNTO 1275 in the treatment of subjects with active Psoriatic Arthritis. |
|
| E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate:
(1) the efficacy of CNTO 1275 in achieving a high level of improvement in arthritis,
(2) the impact of CNTO 1275 on quality of life,
(3) the efficacy of CNTO 1275 on psoriatic skin lesions, and
(4) the pharmacokinetic and pharmacodynamic characteristics of CNTO 1275 in subjects with Psoriatic Arthritis. |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
subjects must meet all of the following criteria:
1. Are 18 years of age or older at time of consent; may be male or female.
2. Have had a diagnosis of PsA at least 6 months prior to the first administration of study agent.
3. Have a diagnosis of active PsA at the time of screening and baseline, as defined by:3 or more swollen joints and 3 or more tender joints
-AND at least one of the following-
Morning stiffness of ≥ 45 minutes
C-reactive protein (CRP) ≥ 1.5 mg/dL
4. Have at least 1 of the PsA subsets: DIP joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
5. Are negative for RF.
6. Have active plaque psoriasis, with a qualifying target lesion of at least 2 cm in diameter, but not on axilla, inframammary area, or groin.
7. Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue to use such measures until 12 months after receiving the last injection of study agent.
8. Are able to adhere to the study visit schedule and other protocol requirements.
9. Are capable of giving informed consent and the consent must be obtained prior to any study related procedures.
10. Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study.
11. Have active arthritis despite current or previous DMARD and/or NSAID therapy, or prior exposure to anti-TNF agents. 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.
12. If using MTX, subjects 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 route of administration and doses (not to exceed 25 mg/week) should be stable for at least 4 weeks prior to the first administration of 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.
13. 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.
14. If using oral corticosteroids, the subject must be on a stable dose equivalent to ≤ 10 mg of prednisone/day for at least 2 weeks prior to the first administration of study agent. If currently not using oral corticosteroids, the subject must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent.
15. Must agree not to receive a live virus or live bacterial vaccination during the trial or up to 12 months after the last study agent injection.
16. Must agree not to receive a bacille Calmette-Guerin (BCG) vaccination during the trial or up to 12 months after the last study agent injection.
17. Have screening laboratory test results within the following parameters:
a. Hemoglobin ≥ 8.5 g/dL (SI: ≥ 85 g/L)
b. White blood cells ≥ 3.5 billion/L (SI: ≥ 3.5 billion cells/L)
c. Neutrophils ≥ 1.5 billion/L (SI: ≥ 1.5 billion cells/L)
d. Platelets ≥ 100 billion/L (SI: ≥ 100 billion cells/L)
e. Serum creatinine ≤ 1.5 mg/dL (SI: ≤ 133 micromol/L)
f. Serum alanine transaminase, aspartate transaminase, and alkaline phosphatase levels must be within 1.5 times the upper limit of normal range
18. 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 a negative tuberculin skin test, or have a newly identified positive tuberculin skin 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. |
|
| E.4 | Principal exclusion criteria |
| 1. Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 12 months after receiving the last administration of study agent.2. Have other inflammatory diseases that might confound the evaluations of benefit of CNTO 1275 therapy, including but not limited to RA, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease.3. Have ever received any therapeutic agent targeted at reducing IL-12 or IL-23, including but not limited to CNTO 1275 and ABT-874.4. Have used any investigational drug within the previous 4 weeks or 5 times the t1/2 of the investigational agent, whichever is longer or 3 months for any biologic of unknown t1/2.5. Have used any biologic within the previous 4 weeks or 5 times the t1/2 of the biologic, whichever is longer.6. Have ever received natalizumab or other agents that target alpha-4-integrin.7. Have ever received rituximab.8. Have received DMARDs other than MTX within 4 weeks prior to the first administration of the study agent.9. Have received leflunomide within 4 weeks prior to the first administration of study agent (irrespective of undergoing a drug elimination procedure), or have received leflunomide within 3 months prior to the first administration of study agent and have not undergone a drug elimination procedure.10. Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PASI evaluation within 4 weeks of the first administration of study agent. 11. Have used topical medications/treatments that could affect psoriasis or PASI evaluation within 2 weeks of the first administration of study agent. Acceptable low-potency corticosteroids include 2.5% concentration or less of hydrocortisone cream or equivalent.12. Have received any systemic immunosuppressives within 4 weeks of the first administration of the study agent.13. Have received intra-articular, intramuscular (IM), or IV corticosteroids, including adrenocorticotropic hormone administered intramuscularly during the 4 weeks prior to the first administration of the study agent.14. Are currently receiving lithium or have received lithium within 4 weeks of the first administration of the study agent.15. 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 12 months after the last administration of study agent.16. Have received, or are expected to receive, a BCG vaccination within 12 months of screening, during the trial, or within 12 months after the last administration of study agent.17. Have a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection, or open, draining, or infected skin wounds or ulcers.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 or have a serious infection, or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening.20. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.21. 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.22. Have or ever had a nontuberculous mycobacterial infection or opportunistic infection.23. Have or have had a herpes zoster infection within 2 months of first administration of study agent.24. Are known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C.25. Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.26. Have a transplanted organ (with exception of a corneal transplant > 3 months prior to the first administration of study agent).27. Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location.28. Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma or squamous cell carcinoma in situ of the skin, cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to randomization).29. Have been hospitalized in the past 3 years for asthma, ever required intubation for treatment of asthma, currently require chronic oral corticosteroids for the treatment of asthma, or required more than one short-term (≤ 2 weeks) course of oral corticosteroids for asthma within the previous year. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary endpoint is the proportion of subjects who achieve an ACR 20 response at Week 12 |
|
| 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 | Information not present in EudraCT |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| 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) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| 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 | Yes |
| E.8.1.6 | Cross over | Yes |
| 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.8.5 | The trial involves multiple Member States | Yes |
| 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 |
|
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| 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
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
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