AzTrials
AzTrials

Rheumatoid ArthritisPhase 4REWARDNCT01405326

REstore Working Ability in RheumatoiD Arthritis

A Phase 4 study testing adalimumab in people with Rheumatoid Arthritis, run by The Rheumatological Center of Helsinki at 4 sites in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of the study is to assess whether a 6-month treatment with adalimumab added on the treatment with conventional antirheumatic drugs (DMARD) will decrease the number of days on sick leave compared to placebo. Read more about this study

Who is it for?
Ages 25 to 55 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
adalimumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
4 sitesFinland
Study dates
May 2011to Mar 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria
  • Time from diagnosis of RA < 2 years
  • Age 25-55 years
  • Active RA with at least 3 active joints (tender and/or swollen joints)
  • Stable DMARD combination treatment for more than 3 months
  • At least one of the following
Show all 16Show fewer
  • Rheumatoid factor positive
  • One or more erosions in x-rays of the hands and feet
  • Anti-citrulline antibodies positive
  • At least other of the following
  • HAQ-index 0.5 or more
  • Patient or physician evaluation of RA activity >25 mm (VAS 0-10 cm)
  • Patient has been steadily in work-life for at least one year and is currently working or on sick- leave but not applying for pension
  • Patient feels that he/she will likely have to be off-work during the following 6 months due to his/her RA
  • Patient must be willing and able to provide written informed consent for the trial
  • Each female subject must agree to use a medically accepted method of contraception while receiving study medication

Who cannot join

  • A subject must not have a history of biological drug use for RA
  • A subject must not have evidence of active or latent tuberculosis,
  • A subject must not have any history of lymphoproliferative disease or malignancy within the previous 5 years
  • A subject must not have any other condition, that according to the investigator's judgment makes him or her non-eligible for anti-TNF use
  • A subject must not have any inflammatory rheumatic disease other than RA
  • A subject must not have received any other investigational agents within 30 days prior to baseline visit, and must not receive them during the current trial
Show all 11Show fewer
  • A female subject must not be pregnant or breast-feeding or planning pregnancy during the study
  • A subject must not have had a major surgery within one month prior to study entry and must not have a scheduled operation during the 6-month follow up
  • A subject must not have any clinically significant condition or situation, other than the condition being studied, that in the opinion of the investigator would interfere with the optimal participation in the trial.
  • A subject must not fulfill the criteria for reimbursement for biologics for RA and he/she would not normally be prescribed a biological drug according to physicians discretion and national treatment guidelines
  • A patient must not be currently on reimbursed rehabilitation period, or such period must not be scheduled for the next six months

Trial locations and contacts

4 sites in 1 country.

Kari K Eklund, MD contact

+358405832866

kari.eklund@welho.com

Kari Puolakka, MD contact

+358408354734

kari.puolakka@eksote.fi

Finland4 sites, 4 recruiting

  • Helsinki University Central Hopsital

    Helsinki, 00029

    Ritva Peltomaa, MD, +35894711, ritva.peltomaa@hus.fi

    Ritva Peltomaa, MD

    Recruiting

  • Lappland Central Hospital

    Rovaniemi, 96101

    Toini Uutela, MD, toini.uutela@lshp.fi

    Toini Uutela, MD

    Recruiting

  • Tampere University hospital, Rheumatology Centre

    Tampere, 33521

    Heidi Mäkinen, MD, heidi.m.makinen@pshp.fi

    Heidi Mäkinen, MD

    Recruiting

  • The Turku Universitry Central Hopsital

    Turku

    Laura Pirilä, MD, laura.pirila@tyks.fi

    Laura Pirilä, MD

    Recruiting

Other trials in Finland

About this study

Official title: The Effect of Six Months Adalimumab Treatment on Sick Leaves and Retirement in Patients With Rheumatoid Arthritis Who Are at a Risk of Losing Their Ability to Work

The purpose of the study is to assess whether a 6-month treatment with adalimumab added on the treatment with conventional antirheumatic drugs (DMARD) will decrease the number of days on sick leave compared to placebo. In addition, the cost-effectiveness and cost-utility of the intervention compared to the conventional treatment is evaluated, and the patients who benefit most are characterized.

Read the detailed description

In spite of the improved medical treatment, rheumatoid arthritis (RA) is still causing both significant morbidity and marked loss of work productivity. Short periods of work inability, i.e., sick leaves represent a significant part of the socioeconomic burden of RA. The study is a randomized, controlled double blind multi-center study. 160 patients of 25 to 55 years of age with recent-onset (≤2 years from diagnosis) RA who have been treated with a combination of conventional antirheumatic drugs but have an inadequate response to treatment and are at the risk of losing their ability to work, are enrolled. The patients should be biologic-naïve. Their RA should be active, but not so active that the conventional criteria for biologic therapy would be fulfilled. The subjects are randomized at 1:1 ratio to receive either adalimumab (40 mg every two weeks) or placebo for 6 months added on their concurrent antirheumatic therapy. The RA-related sickness absence and clinical response will be evaluated.

Being tested
adalimumab
Keywords
rheumatoid arthritis, biological therapy, adalimumab, ability to work, sick leaves
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adalimumabBiological

    Also called Humira

    40mg sc. every two weeks for six months

Study groups in NCT01405326
Study groupRoleWhat they receive
AdalimumabExperimentalAdalimumab treatment for 6 months
Receives: Biological: adalimumab
PaceboPlacebo comparatorCorresponding placebo for active treatment group
Receives: Biological: adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of lost work days due to RA during the 6-month follow up.

    Measured: 6 months

Secondary outcomes (4)

  1. Change in health-related quality of life as measured by the EQ-5D index over the 6-month follow up

    Measured: baseline and 6 months

  2. Change in functionality assessed by the HAQ over the 6-month follow up

    Measured: baseline and 6 months

  3. Change in disease activity measured with DAS28 with CRP and ESR over the 6-month follow up

    Measured: baseline and 6 months

  4. Work Productivity and Activity Impairment Questionnaire (WPAI)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2012 (estimated)
  4. Study completionMar 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01405326
Sponsor's protocol ID
RE100002011
Acronym
REWARD
Status last verified
Jul 2011
First submitted
30 Jun 2011
Last updated
29 Jul 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing adalimumab in people with Rheumatoid Arthritis, run by The Rheumatological Center of Helsinki at 4 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kari K Eklund, MD (+358405832866, kari.eklund@welho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of lost work days due to RA during the 6-month follow up. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01405326.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in