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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01308255
Date of registration: 03/03/2011
Prospective Registration: No
Primary sponsor: University of Leeds
Public title: Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA) IDEA
Scientific title: A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis.
Date of first enrolment: September 2006
Target sample size: 112
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01308255
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
United Kingdom
Contacts
Name:     Paul Emery
Address: 
Telephone:
Email:
Affiliation:  University of Leeds
Key inclusion & exclusion criteria

Inclusion Criteria:

- Men & Women 18-80 years of age.

- Fulfil 1987 ACR criteria for RA.

- Symptoms of > 3 months and < 12 months duration.

- Men and women must use adequate birth control measures for the duration of the study
and should continue such precautions for 6 months after receiving the last infusion or
dose of methotrexate.

- The patient must be able to adhere to the study visit schedule and other protocol
requirements.

- The patient must be capable of giving informed consent and the consent must be
obtained prior to any screening procedures.

- Must have a chest radiograph within 3 months prior to first treatment dose with no
evidence of malignancy, infection or fibrosis.

- Are considered eligible according to the tuberculosis (TB) eligibility assessment.

- Active disease as defined by DAS > 2.4.

- TNF therapy naïve.

- DMARD therapy naïve.

- Negative hepatitis B and C screening tests within 3 months prior to screening.

Exclusion Criteria:

- Women who are pregnant, nursing, or men or women planning pregnancy within 24 months
after screening.

- Use of any investigational (unlicensed) drug within 1 month prior to screening or
within 5 half-lives of the investigational agent, whichever is longer.

- Previous or current treatment with any other therapeutic agent targeted at reducing
TNF.

- Prior treatment with any DMARD.

- Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months.

- Documented HIV infection.

- Hepatitis- B or Hepatitis-C serology positive (must be checked within 3 months prior
to screening).

- Are considered ineligible according to the TB eligibility assessment.

- Have or have had an opportunistic infection within 6 months prior to screening.

- Significant haematological or biochemical abnormality.

- Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral
disease.

- Concomitant congestive heart failure, including medically controlled asymptomatic
patients.

- Presence of a transplanted organ (with the exception of a corneal transplant > 3
months prior to screening).

- Malignancy within the past 5 years.

- History of lymphoproliferative disease including lymphoma, or signs and symptoms
suggestive of possible lymphoproliferative disease.

- Known recent substance abuse (drug or alcohol).

- Poor tolerability of venipuncture or lack of adequate venous access for required blood
sampling during the study period.

- Have a chest radiograph at screening that shows evidence of malignancy, infection, or
any abnormalities suggestive of TB.

- Have a positive Mantoux test or evidence of active TB infection, or recent close
contact with an individual with active TB.

- Previous oral, IM, IA or IV corticosteroids within 1 month prior to baseline.

- Receiving treatment with anakinra.

- Contra-indications to methotrexate, infliximab or steroids.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Dietary Supplement: Folic acid
Drug: Infliximab
Drug: Methotrexate
Drug: Methylprednisolone
Primary Outcome(s)
The primary endpoint is the change in Sharpe van der Heijde score [Time Frame: 50 Weeks]
Secondary Outcome(s)
Health Assessment Questionnaire [Time Frame: 78 Weeks]
Immune phenotyping (flow cytometry) and assessment of immune effector & regulatory functions [Time Frame: 78 Weeks]
Immunogenetic studies to predict long-term immune response [Time Frame: 78 Weeks]
Number of patients having a major clinical response (DAS <1.6 for 6 months) [Time Frame: 78 Weeks]
RA Quality of Life questionnaire [Time Frame: 78 Weeks]
The change in Sharpe van der Heijde scores between baseline, 26 & 72 wk hand & feet x-rays [Time Frame: Week 72]
The number of patients in clinical remission (DAS <1.6) at 26 weeks [Time Frame: 26 Weeks]
The number of patients in clinical remission (DAS <1.6) at 78 weeks [Time Frame: 78 Weeks]
The number of patients in infliximab free remission (DAS <1.6) at 78 weeks [Time Frame: 78 Weeks]
Secondary ID(s)
2005-005013-37
RR05/7092
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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