A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece

2014-07-23 21:09:51 | BioPortfolio


Observe and assess the long-term use, safety and efficacy of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization. Also observe the compliance of the patients with the prescribed treatment.


This is a multi-center, uncontrolled observational study of patients who at the time of entry had moderate to severe rheumatoid arthritis (RΑ) and who were subsequently prescribed Humira (adalimumab) following normal clinical practice, with or without other anti-rheumatic treatments, prior to enrollment in this study.

These patients, at the time of entry had previously failed one or more DMARDs and had active RA despite concomitant RA treatment.

A maximum of 500 patients of either gender may be enrolled in this observational study. Patients must have been treated for at least 1 month with HUMIRA®. Patients must have been thoroughly trained in HUMIRA® injection from their physician or other health care professional. Patients may be enrolled in the PMOS a minimum of 2 weeks and a maximum of 3 months after completing 1 month of HUMIRA® treatment. A patient may only be enrolled in the PMOS once. Approximately 250 physicians will participate in the study, either in hospitals or community. The private practice physicians will be coordinated in groups of up to 30 by a hospital based rheumatologist Patients will be followed for 3 years within the post-marketing observational study. The last date for patient enrollment will be the date of enrolment of the 500th patient.The enrolment period should not exceed 18 months.

Physicians will be provided with a study kit that includes a protocol, patient informed consent forms, serious adverse event report forms, pre-addressed envelopes and Data Report Forms (DRFs) either electronically or on paper, for each patient to be enrolled. Physicians will enroll patients who have been prescribed HUMIRA® for at least one month Physicians are free to determine the appropriate therapy for each patient. The participating physician will already have provided a prescription to the patient for HUMIRA®, along with instructions for appropriate use according to the Summary of Product Characteristics (SPC) in the European Union.

Once the physician has determined that the patient meets the inclusion criteria, and the patient has agreed to be included in the observational study by signing the informed consent, the patient's Day 1 demographic data, and disease status will be reported in the Day 1 Data Report Forms. The physician will then follow-up the patient via regular office visits at intervals as determined by routine clinical practice. Patient's safety and efficacy data if they are part of clinical routine will be recorded in the Data Report Forms at Day 1, and regular visits which are closest to Month 3, Month 6, Month 9, Month 12, Month 18 , Month 24, Month 30 and Month 36. While the physician will likely deem it appropriate and necessary to have the patient return for intermediate visits during the study period, data will be collected via Data Report Forms only at the intervals which correspond closely to those described above. Physicians are encouraged to treat their patients as they would in their routine clinical practice. If treatment with adalimumab is permanently discontinued for any reason, patients will be discontinued from the study and the reason should be recorded. Physicians will be asked to record adverse events up to 3 months after last administration of adalimumab on the Data Report Form of the next scheduled data collection time.

Patients meeting all of the inclusion criteria and who have none of the exclusion criteria may be enrolled in the study.

Study Design

Time Perspective: Prospective


Rheumatoid Arthritis


Site Reference ID/Investigator# 29992
Agioi Anargyroi


Active, not recruiting



Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:09:51-0400

Clinical Trials [1363 Associated Clinical Trials listed on BioPortfolio]

Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis

Primary aim: examine a possible connection between cigarette smoking, disease activity and perceived pain in patients with rheumatoid arthritis. Secondary aim: Evaluate cardiovascular ris...

Safety Study of Abatacept to Treat Rheumatoid Arthritis

The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are tre...

Activity Limitations in Rheumatoid Arthritis

Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Hea...

Rosuvastatin in Rheumatoid Arthritis (RORA)

Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. Our study is aimed at looking at the effects of proven cholesterol lowering treatment drug called ...

A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients

This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by patients with the disease.

PubMed Articles [1148 Associated PubMed Articles listed on BioPortfolio]

MICB*002 and MICB*014 protect against rheumatoid arthritis, whereas MICA*009 and MICA*A6 are associated with rheumatoid arthritis in a Hainan Han Chinese population.

Rheumatoid arthritis (RA) as an inflammatory autoimmune disease affects the synovial joints as well as other organs and tissues. Since aberrant expression of MIC molecules has been observed in RA pati...

Methotrexate did not improve endothelial function in rheumatoid arthritis: a study in rats with adjuvant-induced arthritis.

Rheumatoid arthritis is associated with an increased cardiovascular risk, secondary to endothelial dysfunction. There is accumulating evidence that methotrexate reduces cardiovascular risk in rheumato...

Rheumatoid arthritis in remission : Decreased myostatin and increased serum levels of periostin.

Chronic inflammation of rheumatoid arthritis (RA) is associated with disturbances in muscle and bone metabolism.

Effects of TNF-α in rheumatoid arthritis via attenuating α1 (I) collagen promoter.

To explore the role of TNF-α in the peripheral blood of patients with rheumatoid arthritis (RA) and its underlying mechanism.

Recombinant interferon alpha 2b in rheumatoid arthritis: good antigen for rheumatoid arthritis antibodies.

Interferon alpha-induced arthritis and activation of the type 1 interferon pathway during rheumatoid arthritis (RA) has been well documented but the underlying mechanism remains unclear. This study ad...

Medical and Biotech [MESH] Definitions

Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

A variable mixture of the mono- and disodium salts of gold thiomalic acid used mainly for its anti-inflammatory action in the treatment of rheumatoid arthritis. It is most effective in active progressive rheumatoid arthritis and of little or no value in the presence of extensive deformities or in the treatment of other forms of arthritis.

Systemic-onset rheumatoid arthritis in adults. It differs from classical rheumatoid arthritis in that it is more often marked by acute febrile onset, and generalized lymphadenopathy and hepatosplenomegaly are more prominent.

Antibodies found in adult RHEUMATOID ARTHRITIS patients that are directed against GAMMA-CHAIN IMMUNOGLOBULINS.

More From BioPortfolio on "A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece"

Quick Search


Relevant Topic

Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...

Searches Linking to this Trial