A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade®) in Combination with Methotrexate in Patients with Very Early Inflammatory Arthritis - DINORA

Phase 1

• Conditions: Earliest clinically perceptible phase of arthritis. Classification criteria to delineate this group of patients are not available. Therefore eligibility will be based on three important criteria: 1) the duration of arthritis-symptoms, as evaluated by the patient; and 2) the presence of arthritis, as documented by the rheumatologist; and 3) the persistence of arthritis, as documented by a rheumatologist.; MedDRA version: 9.1Level: PTClassification code 10003246Term: Arthritis

• Registration Number: EUCTR2006-002787-26-ES
• Lead Sponsor: Vienna Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-12
• Study Completion: 2014-08-31
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

All patients to be included into this trial must meet the following inclusion criteria:
1)Men and women, = 18 and = 75 years of age, capable of understanding and signing an informed consent.
2)The presence of arthritis:
a)Must be established in a rheumatology center,
b)Must be present in at least 2 joints of the 66 joint count, of which at least one joint must be an MCP-, or a PIP- (IP-) or a wrist- or a MTP-joint. Two MTP-joints will not suffice. Any kind of polyarthritis (= 6 joints of any kind) will be sufficient.
c)Without any previous episodes of inflammatory joint disease
3)Duration of symptoms :
a)Must be assessed by the subject and should involve the inflamed joints described under 2.
b)Must be 2 weeks at least, according to the algorithm in Table 1 (subjects will not receive study treatment before 12 weeks of symptom duration according to the algorithm in Table 1)
c)Must be 16 weeks at most, as assessed by the subject, including the observation period of at least 2 weeks by the physician, according to the algorithm in Table 1.
4)Confirmation of persistent arthritis:
a)Duration must be 2 weeks at least, according to the algorithm in Table 1.
b)Duration must be 12 weeks at most, according to the algorithm in Table 1.
c)Must be documented by the same rheumatology center that established arthritis at the first visit
d)Must involve at least one of the same joints as were involved at the first visit
5)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 medication.
6)Are considered eligible according to the tuberculosis (TB) eligibility assessment, screening, and early detection of reactivation rules defined in Section 7.14: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation
7)Chest radiograph (which must not be older than three months at the visit 1/day 0 visit) must show no evidence of malignancy, infection, or fibrosis. The chest radiograph should also show no atypical scarring, cavitary lesions, or calcified granulomas, as evidence of past tuberculosis infections, without a documented history of adequate therapy.

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 must not
1)Have arthritis with a distinct diagnosis, made after a routine diagnostic work-up (examples are SLE, psoriatic arthritis, systemic sclerosis, gout, pseudogout, Lyme arthritis, reactive arthritis, Parvo viral arthritis)
2)Be incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for self care.
3)Weigh more than 100 kg
4)Use glucocorticoids > 10 mg/day prednisone or equivalent
5)Have received Intramuscular or intra-articular injection of steroids in the previous month.
6)Have Screening laboratory test results as follows:
a)White blood cells (WBCs) < 3.0 x 109 cells/L
b)Platelets < 100 X 109 cells/L
c)Serum creatinine > 1.4 mg/dL
d)Serum transaminase levels exceeding 2 times the upper limit of normal for the site laboratory
7)Have had any previous treatment with monoclonal antibodies or antibody fragments.
8)Have a history of receiving human/murine recombinant products or a known allergy to murine products. A known allergy to murine product is definitely an exclusion criterion.
9)Have had prior treatment with MTX and/or other DMARDs (except hydroxychloroquine).
10)Have documentation of seropositivity for human immunodeficiency virus (HIV).
11)Have documentation of a positive test for hepatitis B surface antigen or hepatitis C-antibodies.
12)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.
13)Have a known history of serious infections (such as, but not limited to hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
14)Have a known history of a demyelinating disease, such as multiple sclerosis
15)Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 12 months prior to screening.
16)Have undergone any joint replacement surgery.
17)Have a chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg. bronchiectasis), sinusitis, recurrent urinary tract infection, open, draining or infected skin wound or ulcer.
18)Be considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section on: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation Rules
19)Have a chest radiograph at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB.
20)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.
21)Currently have any known malignancy other than the condition being treated 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.
22)Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
23)Be unable or unwilling to undergo mul

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified