Study Comparing Conventional Therapy and Biologic Treatments for Early Rheumatoid Arthritis Using Hydroxychloroquine, Abatacept, and Azathioprine in Responsive Patients

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What is this study about?

This clinical trial is focused on studying Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study aims to compare the effectiveness of different treatments for this disease. The treatments being tested include both conventional and biologic therapies. Conventional therapies involve medications like Hydroxychloroquine, Azathioprine, Sulfasalazine, Methotrexate, Leflunomide, and Betamethasone. Biologic therapies include medications such as Certolizumab Pegol, Tocilizumab, and Abatacept. These treatments are administered in various forms, including oral tablets, subcutaneous injections (injections under the skin), and infusions (a method of delivering medication directly into the bloodstream).

The purpose of the study is to assess how well patients achieve remission, which means a reduction or disappearance of symptoms, with these treatments. The study will also explore two different strategies for reducing the dosage of medication in patients who respond well to the initial treatment. Participants will be randomly assigned to receive either conventional therapy or one of the biologic treatments. The study will monitor the participants over a period to see how their condition improves and whether they can maintain remission with reduced medication.

Throughout the study, participants will receive regular assessments to track their progress. These assessments will help determine the effectiveness of the treatments and the best approach for managing Rheumatoid Arthritis. The study is designed to provide valuable information on how different treatments can help patients achieve and maintain remission, ultimately improving their quality of life.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests.

A chest X-ray and an electrocardiogram (ECG) are performed to ensure good general health.

2 treatment allocation

Participants are randomly assigned to receive either active conventional therapy or one of three biologic treatments.

The specific treatment plan is determined based on the study’s randomization process.

3 medication administration

Medications are administered according to the assigned treatment group. This may include oral medications such as hydroxychloroquine, azathioprine, or sulfasalazine, or injections such as abatacept or certolizumab pegol.

The frequency and dosage depend on the specific medication and treatment plan.

4 monitoring and follow-up

Regular follow-up visits are scheduled to monitor health and response to treatment. This includes assessments of joint swelling and tenderness, as well as blood tests to measure inflammation levels.

Adjustments to the treatment plan may be made based on these assessments.

5 evaluation of remission

At week 24, the primary outcome is evaluated to determine if remission has been achieved. This is assessed using the Clinical Disease Activity Index (CDAI).

If remission is achieved, the study may proceed to a de-escalation phase where medication doses are gradually reduced.

6 de-escalation phase

For participants who respond to treatment, a de-escalation strategy is implemented. This involves reducing the dosage of medications over a specified period.

The goal is to maintain remission with the lowest effective dose.

7 final assessment

The study concludes with a final assessment to evaluate the long-term effects of the treatment and the success of the de-escalation strategy.

Participants are monitored for any changes in their condition and overall health.

Who Can Join the Study?

The person must be at least 18 years old.
The person must be able and willing to sign a form agreeing to participate and follow the study rules.
The person must be able and willing to give themselves injections under the skin, or have someone qualified to do it for them.
The person must have a diagnosis of Rheumatoid Arthritis (RA) according to specific criteria set in 2010.
The person must have had arthritis symptoms for less than 24 months.
The person must have a DAS28 (CRP) score greater than 3.2. This is a measure of RA activity based on joint swelling and tenderness.
The person must have at least 2 swollen joints and at least 2 tender joints.
The person must meet one of the following: be RF positive (Rheumatoid Factor), ACPA positive (Anti-Citrullinated Protein Antibody), or have a CRP (C-reactive protein) level of 10 mg/L or higher.
If the person is a woman who can have children, she must use a reliable method of birth control during the study and for 150 days after it ends. Options include an intrauterine device (IUD), contraceptives like pills or patches, or having a partner who has had a vasectomy.
Women who can have children must have a negative pregnancy test before starting the study.
The person must be in good general health, as determined by the study doctor, based on medical history, lab tests, physical exam, chest X-ray, and heart test (ECG) done before the study starts.

Who Cannot Join the Study?

Patients who have a different condition than Rheumatoid Arthritis cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, so it’s important to check if you fit within it.
Patients who are part of a vulnerable population, which means groups that might need special protection, cannot participate.
Patients who do not respond to the first-line therapy, which is the initial treatment given for a condition, cannot participate in the de-escalation strategies part of the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Falu lasarett	Falun	Sweden

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
St. Olavs Hospital HF	Trondheim	Norway
Regionshospitalet Silkeborg	Silkeborg	Denmark
Diakonhjemmet Sykehus AS	Oslo	Norway
Odense University Hospital	Odense	Denmark
Karolinska University Hospital	Solna	Sweden
Aalborg University Hospital	Aalborg	Denmark
Sahlgrenska Universitetssjukhuset	Gothenburg	Sweden
Doheq Gjbkcaeghzfl	Sønderborg	Denmark
Uqjyqoujcwxtjolnowzkn Öcdgec	Orebro	Sweden
Asgdptvgff seqoojgll	Uppsala	Sweden
Ssqtap Uarmtltonwbnhacqzdhg Lujr	Lund	Sweden
Rmkqvnrqyimu Sbrrcmyngwl Ubsfysurnfamrqmfkbilbgxdbvmjq	Molndal	Sweden
Ubxduglgpuiprpawwtspo i Ltbbdgapu	Linkoping	Sweden
Cwuahyb fyo rvddtmalmdd	Stockholm	Sweden
Sljxdl Uvlhrjubjovezjxezwd Msdnp	Malmo	Sweden
Hvlbu Bzjsxy Hs	Bergen	Norway
Aptfuq Uooduseqsa Hpfiumhy	Aarhus	Denmark
Hitlk Mjfly Om Rqazkcy Hk	Aalesund	Norway
Rbzzzampqulgdz	Glostrup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	14.12.2012
Iceland	Not yet recruiting	14.12.2012
Norway	Not yet recruiting	14.12.2012
Sweden	Not yet recruiting	14.12.2012

Trial locations

Investigated drugs:

Methotrexate is a medication used as part of active conventional therapy for treating early rheumatoid arthritis. It helps reduce inflammation and slow down the progression of the disease by affecting the immune system.

Adalimumab is a biologic therapy used to treat rheumatoid arthritis. It works by blocking a specific protein in the body that causes inflammation, helping to reduce symptoms and prevent joint damage.

Etanercept is another biologic treatment option for rheumatoid arthritis. It acts by interfering with the inflammatory process in the body, which can help alleviate pain and swelling in the joints.

Tocilizumab is a biologic medication used in the treatment of rheumatoid arthritis. It targets and blocks a specific receptor involved in the inflammatory process, helping to control symptoms and improve joint function.

Investigated diseases:

Rheumatoid arthritis

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the small joints of the hands and feet. Over time, it can lead to joint damage and deformities. The disease may also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. It progresses through periods of flares and remissions, where symptoms can worsen or improve. The exact cause is unknown, but it involves the immune system attacking the body’s own tissues.

Trial ID:

2024-516723-14-00

Protocol code:

NORD-STAR

NCT ID:

NCT01491815

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Conventional Therapy and Biologic Treatments for Early Rheumatoid Arthritis Using Hydroxychloroquine, Abatacept, and Azathioprine in Responsive Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?