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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 25 November 2019
Main ID:  EUCTR2005-005013-37-GB
Date of registration: 20/01/2006
Prospective Registration: Yes
Primary sponsor: University of Leeds
Public title: A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA
Scientific title: A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA
Date of first enrolment: 06/04/2006
Target sample size: 112
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005013-37
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: yes
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
United Kingdom
Contacts
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Affiliation: 
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Key inclusion & exclusion criteria
Inclusion criteria:
1. Men and women 18-80 years of age.
2. Fulfil 1987 ACR Criteria for RA .
3. Symptoms of >3 months and <12 months duration
4. Men and women must use adequate birth control measures (eg, abstinence, oral contraceptives, Intra-uterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion or dose of methotrexate.
5. The patient must be able to adhere to the study visit schedule and other protocol requirements.
6. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.
7. Must have a chest radiograph within 3 months prior to first treatment dose with no evidence of malignancy, infection or fibrosis.
8. Are considered eligible according to the tuberculosis (TB) eligibility assessment, screening, and early detection of reactivation rules defined in Section 4.3.
9. Active disease as defined by DAS 44= 2.4.
10. TNF naïve.
11. DMARD naïve.
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:
1. Women who are pregnant, nursing, or planning pregnancy within 24 months after screening (ie, approximately 6 months following last study medications).
2. Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
3. Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline, thalidomide, infliximab, adalimumab etc.)
4. Prior treatment with any DMARD other than antimalarials.
5. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.
6. Documented HIV infection.
7. Documented hepatitis- B or hepatitis-C.
8. Are considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section 4.3.
9. Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
10. Significant haematological or biochemical abnormality
a. Haemoglobin ?8.5 g/dL
b. WBC ?3.5 x 109/L
c. Neutrophils ?1.5 x 109/L
d. Platelets ?100 x 109/L
e. ALT and AST ?3 times ULN for the laboratory conducting the test.
f. Creatinine > 1.5 times normal
11. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
12. Concomitant congestive heart failure, including medically controlled asymptomatic patients.
13. Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening).
14. Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
15. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
16. Known recent substance abuse (drug or alcohol).
17. Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
18. Have a chest radiograph at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB as described in Section 4.3.2.1
19. Have a positive Mantoux test or Evidence of active TB infection, or recent close contact with an individual with active TB.
20. Previous oral, IM, IA or IV corticosteroids within 1 month.
21. Receiving treatment with anakinra.
22. Currently participating in another drug trial.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Early Rheumatoid Arthritis
Intervention(s)

Trade Name: Remicade
Product Name: Remicade
Product Code: Infliximab
Pharmaceutical Form: Powder for solution for infusion

Trade Name: Mextrex
Product Name: Methotrexate
Product Code: Mextrex
Pharmaceutical Form: Tablet
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: Methotrexate
Concentration unit: mol/mg mole(s)/milligram
Concentration type: equal
Concentration number: 10-

Trade Name: Ferrograd Folic Tablets

Product Name: Folic Acid
Product Code: Ferrograd
Pharmaceutical Form: Tablet
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: Folic Acid
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 350-

Trade Name: Solu-Medrone 2 Gram
Product Name: Methylprednisolone
Product Code: Solu-Medrone 2 Gram
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: Methylprednisolone
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-

Trade Name: Solu-Medrone 2 Gram
Product Name: Methylprednisolone
Product Code: Solu-Medrone 2 Gram
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: n/a
CAS Number: n/a
Current Sponsor code: n/a
Other de
Primary Outcome(s)

Secondary Objective: 1. The number of patients having a major clinical response.
2. The change in Sharpe van Der Heijde scores between baseline and 26 and 78 weeks.
3. The number of patients in clinical remission at 78 weeks.
4. The number of patients in clinical remission at 26 weeks, no longer on Infliximab / placebo infusions.
5. The number of patients in clinical remission at 78 weeks, no longer on Infliximab / placebo infusions.
6. The number of patients in clinical remission at 26 weeks.
7. RA Quality of Life questionnaire.
8. Health assessment questionnaire.
9. Immunogenetic studies to predict long term immune response.
10. Immune phenotype (flowcytometry) and assessment of immune effector and regulatory functions.
11. Assessment of serum and plasma markers to predict response to therapy and vascular function.
Main Objective: To determine whether use of Biologic Therapy (infliximab) as induction therapy in early rheumatoid arthritis results in less radiographic damage over 78 weeks compared to current best practice therapy: that is early introduction of DMARD in combination with steroid induction therapy and dose modification according to pre defined disease activity measures.
Primary end point(s): Change in Sharpe van Der Heijde score at 78 weeks
Secondary Outcome(s)
Secondary ID(s)
IDEA v1
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available: Yes
Date Posted: 04/01/2017
Date Completed: 18/05/2011
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-005013-37/results
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