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AzTrials

Arthritis, RheumatoidPhase 4ADMIRENCT00808509

A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission

A Phase 4 study testing adalimumab and methotrexate in people with Arthritis, Rheumatoid, run by AbbVie (prior sponsor, Abbott) at 8 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this pilot study is to investigate the possibility of discontinuing adalimumab therapy in patients with rheumatoid arthritis who are in stable remission after treatment with adalimumab in combination with methotrexate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
adalimumab and methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
8 sitesSweden
Study dates
Jan 2009to Sep 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years.
  • Diagnosis of RA as defined by the 1987-revised American College of Rheumatology (ACR)-classification and has positive rheumatoid factor (RF) test or erosion on X-ray of hands or feet.
  • Currently treated with adalimumab and MTX (at least 10 mg/week; orally or subcutaneously).
  • In remission as defined by disease activity score (DAS)28 <2.6 for at least the past 3 months.
  • Concomitant disease-modifying anti-rheumatic drug (DMARD) or oral corticosteroid therapy has been stable for at least 3 months at study entry.
  • Female subject is either not of childbearing potential or is practicing a relevant method of birth control.
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  • Subject is judged to be in good general health.
  • Subjects must be able and willing to provide written informed consent.
  • Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.

Who cannot join

  • Treatment with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks.
  • Oral prednisone or prednisone equivalent > 10 mg/day at baseline.
  • Joint surgery within the preceding two months.
  • History of acute inflammatory joint disease other than RA.
  • Treatment with any investigational drug within 30 days or 5 half lives, whichever is longer prior to study entry.
  • Poorly controlled medical condition, which would put the subject at risk by participation in the study.
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  • History of clinically significant hematologic, renal or liver disease.
  • Diagnosis of, or history suggestive of, central nervous system (CNS) demyelinating disease.
  • History of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma of the cervix.
  • History of listeriosis, histoplasmosis, untreated tuberculosis (TB), persistent chronic infections, or recent active infections.
  • Known immune deficiency or human immunodeficiency virus (HIV).
  • Female who is pregnant or breast-feeding or considering becoming pregnant or breast feeding during the study.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Sweden8 sites

  • Site Reference ID/Investigator# 22062

    Linköping, 581 85

  • Site Reference ID/Investigator# 14022

    Lund, 22185

  • Site Reference ID/Investigator# 14023

    Malmö, 20502

  • Site Reference ID/Investigator# 14301

    Oskarström, 31392

  • Site Reference ID/Investigator# 20241

    Skövde, 54185

  • Site Reference ID/Investigator# 4918

    Stockholm, 171 76

  • Site Reference ID/Investigator# 14021

    Stockholm, SE-141 86

  • Site Reference ID/Investigator# 14302

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission (ADMIRE)

The purpose of this pilot study is to investigate the possibility of discontinuing adalimumab therapy in patients with rheumatoid arthritis who are in stable remission after treatment with adalimumab in combination with methotrexate.

Read the detailed description

Treatments with adalimumab and other tumor necrosis factor (TNF) blockers, once started as therapy for rheumatoid arthritis (RA), are usually continued indefinitely. Information concerning the possibility of discontinuing anti-TNF therapy in RA patients who are in remission is limited. This is a pilot study in one country to study the effect of adalimumab discontinuation. The objective is to assess the proportion of patients with established RA in stable remission (Disease Activity Score [DAS]28 <2.6) after treatment with adalimumab in combination with methotrexate, in whom it is possible to discontinue adalimumab and to compare the remission rates among patients on sustained therapy with adalimumab + methotrexate with remission rates among patients who discontinued adalimumab.

Rheumatoid arthritis patients in stable remission (DAS28 < 2.6) treated with adalimumab + methotrexate were randomized in a 1:1 ratio to continue with adalimumab treatment or discontinue adalimumab treatment for the following 52 weeks. Subsequently an observational extension was conducted to observe patients treated at the discretion of the investigator. The observational extension period lasted until Weeks 105 - 156 (average Week 125) and consisted of one follow-up visit. Participants randomized to discontinue adalimumab therapy will be reinstituted to adalimumab if DAS28-score increases by >1.2 units from baseline and/or is scored ≥2.6 at any visit during the study and will be followed for an additional 12 weeks.

Keywords
adalimumab,Remission,drug discontinuation
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 ABT-D2E7, HUMIRA

    40 mg every other week via subcutaneous injection

  • methotrexateDrug

    At least 10 mg/week administered orally or subcutaneously

Study groups in NCT00808509
Study groupRoleWhat they receive
Adalimumab + MTXActive comparatorParticipants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
Receives: Biological: adalimumab; Drug: methotrexate
MethotrexateExperimentalParticipants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
Receives: Drug: methotrexate

What is being measured

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

  1. Percentage of Participants in Remission at Week 28

    Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

    In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission.

    Measured: Week 28

  2. Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2)

    Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

    In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission.

    Measured: Week 28

Secondary outcomes (43)

  1. Percentage of Participants in Remission at Week 52

    Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

    In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52. Also, participants who did not complete 52 weeks were considered not in remission.

    Measured: Week 52

  2. Percentage of Participants in Remission at Week 52 (FAS2)

    Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Also, participants who did not complete 52 weeks were considered not in remission.

    In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52.

    Measured: Week 52

  3. Number of Participants With a Flare

    Flare is defined as DAS28 ≥2.6 or an increase from Baseline in the DAS28 of greater than 1.2 units. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

    Measured: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, and 52

  4. Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare

    For participants with a flare and treated with adalimumab rescue therapy, response was defined as return to Baseline DAS28 + ≤ 10% after reinstitution of adalimumab (rescue therapy).

    The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

    Measured: 1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy

  5. Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare

    For participants with a flare and treated with adalimumab rescue therapy, response was defined as DAS28 less than 2.6 or DAS28 decrease of greater than 1.2 units after reinstitution of adalimumab (rescue therapy). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.

    Measured: 1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy

  6. Health Assessment Questionnaire (HAQ) Total Score by Visit

    Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.

    Measured: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

  7. European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit

    The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their mobility health state:

    Level 1: I have no problems in walking about;

    Level 2: I have some problems in walking about;

    Level 3: I am confined to bed.

    Measured: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

  8. European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit

    The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their self-care health state:

    Level 1: I have no problems with self-care;

    Level 2: I have some problems washing or dressing myself;

    Level 3: I am unable to wash or dress myself.

    Measured: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

  9. European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit

    The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state with regard to usual activities (work, study, housework, family, or leisure activities):

    Level 1: I have no problems performing my usual activities;

    Level 2: I have some problems performing my usual activities;

    Level 3: I am unable to perform my usual activities.

    Measured: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

  10. European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit

    The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their pain/discomfort health state:

    Level 1: I have no pain or discomfort;

    Level 2: I have moderate pain or discomfort;

    Level 3: I have extreme pain or discomfort.

    Measured: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

  11. European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit

    The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their anxiety/depression health state:

    Level 1: I am not anxious or depressed;

    Level 2: I am moderately anxious or depressed;

    Level 3: I am extremely anxious or depressed.

    Measured: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

  12. European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit

    The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (0) and 'Best imaginable health state' (100).

    Measured: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

  13. Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit

    The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.

    Measured: Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)

  14. Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 1, participants selected either Yes or No if the following statement currently applied to them or not: I'm getting up earlier because of the arthritis.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  15. Work Instability Score (WIS) for RA: I Get Very Stiff at Work

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 2, participants selected either Yes or No if the following statement currently applied to them or not: I get very stiff at work.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  16. Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 3, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding my job is about all I can manage.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  17. Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 4, participants selected either Yes or No if the following statement currently applied to them or not: The stress of my job makes my arthritis flare.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  18. Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 5, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding any pressure on my hands is a problem.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  19. Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 6, participants selected either Yes or No if the following statement currently applied to them or not: I get good days and bad days at work.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  20. Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 7, participants selected either Yes or No if the following statement currently applied to them or not: I can get my job done, I'm just a lot slower.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  21. Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 8, participants selected either Yes or No if the following statement currently applied to them or not: If I don't reduce my hours I may have to give up work.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  22. Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 9, participants selected either Yes or No if the following statement currently applies to them or not: I am very worried about my ability to keep working.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  23. Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 10, participants selected either Yes or No if the following statement currently applies to them or not: I have pain or stiffness all the time at work.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  24. Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 11, participants selected either Yes or No if the following statement currently applies to them or not: I don't have the stamina to work like I used to.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  25. Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 12, participants selected either Yes or No if the following statement currently applies to them or not: I have used my vacation so that I don't have to take sick leave.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  26. Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 13, participants selected either Yes or No if the following statement currently applies to them or not: I push myself to go to work because I don't want to give in to the arthritis.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  27. Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 14, participants selected either Yes or No if the following statement currently applies to them or not: Sometimes I can't face being at work all day.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  28. Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 15, participants selected either Yes or No if the following statement currently applies to them or not: I have to say no to certain things at work.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  29. Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 16, participants selected either Yes or No if the following statement currently applies to them or not: I've got to watch how much I do certain things at work.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  30. Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 17, participants selected either Yes or No if the following statement currently applies to them or not: I have great difficulty opening some of the doors at work.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  31. Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 18, participants selected either Yes or No if the following statement currently applies to them or not: I have to allow myself extra time to do some jobs.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  32. Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 19, participants selected either Yes or No if the following statement currently applies to them or not: It's very frustrating because I can't always do things at work.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  33. Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 20, participants selected either Yes or No if the following statement currently applies to them or not: I feel I may have to give up work.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  34. Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 21, participants selected either Yes or No if the following statement currently applies to them or not: I get on with the work but afterwards I have a lot of pain.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  35. Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 22, participants selected either Yes or No if the following statement currently applies to them or not: When I'm feeling tired all the time work is a grind.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  36. Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do

    Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 23, participants selected either Yes or No if the following statement currently applied to them or not: I'd like another job but I am restricted to what I can do.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  37. Work Productivity and Activity Impairment (WPAI): Currently Employed

    The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 1 asks participants to indicate if they are currently employed or working for pay (Yes or No).

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  38. Work Productivity and Activity Impairment (WPAI): Hours Missed From Work

    The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 2 asks participants who are employed or working for pay to indicate the number of hours missed from work due to problems associated with their rheumatoid arthritis.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  39. Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons

    The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 3 asks participants who are employed or working for pay to indicate the number of hours missed from work due to reasons other than rheumatoid arthritis.

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  40. Work Productivity and Activity Impairment (WPAI): Hours Worked

    The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 4 asks participants who are employed or working for pay to indicate the number of hours actually worked during the past 7 days.

    Measured: Baseline and at Weeks 12, 28, 52 and 104-156

  41. Work Productivity and Activity Impairment (WPAI): Work Productivity

    The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 5 asks participants who are employed or working for pay to indicate how much their rheumatoid arthritis impaired their productivity while working in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from working).

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  42. Work Productivity and Activity Impairment (WPAI): Daily Activities

    The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 6 asks participants to indicate how much their rheumatoid arthritis affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying, etc, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).

    Measured: Baseline and at Weeks 12, 28, 52, and 104-156

  43. Change From Baseline in Radiological Modified Total Sharp Score

    The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage. X-rays of hands and feet were taken at Baseline, Week 52 and the Week 104-156 visit. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

    Measured: Baseline, Week 52, and Weeks 104-156

Timeline

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

  1. First posted16 Dec 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionSep 2012
  4. Study completionSep 2012

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
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00808509
Sponsor's protocol ID
W10-046
Other IDs
2008-004398-16, 2008
Acronym
ADMIRE
Status last verified
Nov 2013
First submitted
12 Dec 2008
Last updated
16 Dec 2013
Data monitoring committee
No

Publications

  • Chatzidionysiou K, Turesson C, Teleman A, Knight A, Lindqvist E, Larsson P, Coster L, Forslind K, van Vollenhoven R, Heimburger M. A multicentre, randomised, controlled, open-label pilot study on the feasibility of discontinuation of adalimumab in established patients with rheumatoid arthritis in stable clinical remission. RMD Open. 2016 Jan 14;2(1):e000133. doi: 10.1136/rmdopen-2015-000133. eCollection 2016.

    PubMed 26819752

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing adalimumab and methotrexate in people with Arthritis, Rheumatoid, run by AbbVie (prior sponsor, Abbott) at 8 sites in Sweden.

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 9 inclusion and 12 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: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Sweden. 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. 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?

Yes. Results are posted in the registry (first posted 20 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants in Remission at Week 28 (time frame: Week 28). The study lists 2 primary outcomes in all. 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 NCT00808509, which also lists 1 linked publication.

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 16 Dec 2013.

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