A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2004-003299-12-FI
• Date of registration: 28/12/2005
• Prospective Registration: Yes
• Primary sponsor: Janssen Biologics B.V.
• Public title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA
• Date of first enrolment: 26/04/2006
• Target sample size: 345
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-003299-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, Finland, Germany, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Are women or men 18 years of age or older.
2. Have a diagnosis of definite AS for at least 3 months prior to first administration of study agent.
Both the radiographic criterion and at least 1 clinical criterion must be met:
a. Radiographic criterion: Sacroiliitis Grade equal to or more than 2 bilaterally or sacroiliitis Grade 3 to 4 unilaterally.
b. Clinical criteria (at least 1):
1) Low back pain and stiffness for more than 3 months, which improves with exercise, but is not relieved by rest
2) Limitation of motion of the lumbar spine in both the sagittal and frontal planes
3) Limitation of chest expansion relative to normal values corrected for age and sex
3. Have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of equal to or greater than 4 and a VAS score for total back pain of equal to or greater than 4, each on a scale of 0 to 10 cm.
4. Either has an inadequate response to 3 months of continuous therapy with maximal recommended doses of NSAID(s), or is unable to receive a full 3 months of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs.
5. 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 drug.
6. 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 first administration of the study drug.
7. If using MTX, SSZ, or HCQ, 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 the DMARD. 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 using SSZ or HCQ, must also be on a stable dose for at least 4 weeks prior to the first administration of study agent. If currently not using MTX, SSZ, or HCQ, must have not received these DMARDs for at least 4 weeks prior to the first administration of the study agent.
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
Exclusion criteria:
1. Have other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy, including but not limited to, RA, PsA, 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 complete ankylosis of the spine, defined as bridging syndesmophytes present at all intervertebral levels of the cervical and lumbar spine visualized on lateral-view spinal radiographs.
4. Have received any systemic immunosuppressives or DMARDs, other than MTX, SSZ, or HCQ within 4 weeks prior to first administration of study agent. Medications in these categories include, but are not limited to azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine.
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 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 TNFa, 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-Guerin (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 first administration of study agent. Less serious infections need not be considered exclusionary at the discretion of the investigator.
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 mult

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis (AS)

Intervention(s)

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 and-100
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 and-100
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 14

Secondary Objective: to assess:
1. The overall safety of golimumab
2. The effects of golimumab on physical function, range of motion, structural damage, and quality of life in subjects with AS
3. The population pharmacokinetic (PK) and pharmacodynamics (PD) effects of golimumab in subjects with AS.

Main Objective: to assess the efficacy of SC injections of golimumab in subjects with active AS as measured by reduction in the signs and symptoms of active AS at Week 14

Secondary ID(s)

C0524T09