An Open Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC (European Ankylosing Spondylitis Infliximab Cohort) - EASIC

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2005-002460-29-DE
• Date of registration: 05/07/2005
• Prospective Registration: Yes
• Primary sponsor: Rheumazentrum Ruhrgebiet.
• Public title: An Open Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC (European Ankylosing Spondylitis Infliximab Cohort) - EASIC
• Scientific title: An Open Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC (European Ankylosing Spondylitis Infliximab Cohort) - EASIC
• Date of first enrolment: 12/09/2005
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002460-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium, Finland, Germany, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Patients to be included must meet the following criteria:

1) All patients in Europe who have completed visit “week 96” of EASIC

2) Have the capacity to understand and sign an informed consent form, are capable of reading and understanding subject assesment forms, and are willing and able to adhere to the study visit schedule and other protocol requirements.

3) Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.

4) The screening laboratory test results must meet the following criteria:
a) Hemoglobin for males ³ 9.0 g/dL (5.6 mmol/L) and females ³ 8.5 g/dL (5.3 mmol/L)
b) Serum transaminase levels must be within 3 times the upper limit of normal range for the laboratory.
c) Serum creatinine = 1.4 mg/dL (123.8 µmol/L).



Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients will be excluded from this study for any of the following reasons:
1) General medical exclusion criteria
a) Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion).
b) Documentation of seropositive for human immunodeficiency virus (HIV).
c) Documentation of a positive test for hepatitis B surface antigen or hepatitis C.
d) Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results.
e) Have a known history of serious infections (eg, hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
f) Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, coccidioidomycosis or mycobacteria other than TB) within 6 months prior to screening.
g) Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
h) Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
i) Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
j) Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
k) Use of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
l) Presence of a transplanted solid organ (excluding a corneal transplant)
m) Have a concomitant diagnosis or history of congestive heart failure.
n) Have a history of latent or active TB prior to screening.
o) Have signs or symptoms suggestive of active TB upon medical history and/or physical examination.
p) Have had a recent close contact with a person with active TB. If there has been such contact, a patient 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.
q) Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months prior to screening.




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

Health Condition(s) or Problem(s) studied

Ankylosing spondylitis (AS)

Intervention(s)

Product Name: Remicade
Product Code: cA2
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Infliximab
Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain)
Concentration unit: mg milligram(s)
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): The primary endpoint is the change in radiographic progression using mSASSS after 6 years of infliximab treatment.

Main Objective: The primary objective of this extension study is to analyze the degree of structural damage (radiographic progression) after 6 years of infliximab therapy. (2 years of ASSERT Trial plus 2 years of EASIC Trial plus 2 years of EASIC extension trial).

Secondary Objective: Secondary objectives include:

1.To study the long-term efficacy of infliximab over 6 years of therapy, measured by the ASAS response criteria
2.To study the long-term safety of infliximab over 6 years of therapy
3.To describe the the long-term effects of infliximab on quality of life
4.To describe the long-term effect on health resource utilisation and productivity in paid and unpaid work
5.To study the long-term efficacy of infliximab over 6 years of therapy, measured by spinal MRI

Secondary ID(s)

EASIC30505