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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: adalimumab (Biological); methotrexate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Mikael Heimburger, MD, Study Director, Affiliation: AbbVie AB

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Percentage of Participants in Remission at Week 28

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

Secondary outcome:

Percentage of Participants in Remission at Week 52

Percentage of Participants in Remission at Week 52 (FAS2)

Number of Participants With a Flare

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

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

Health Assessment Questionnaire (HAQ) Total Score by Visit

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Work Productivity and Activity Impairment (WPAI): Currently Employed

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

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

Work Productivity and Activity Impairment (WPAI): Hours Worked

Work Productivity and Activity Impairment (WPAI): Work Productivity

Work Productivity and Activity Impairment (WPAI): Daily Activities

Change From Baseline in Radiological Modified Total Sharp Score

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

- 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. Exclusion Criteria:

- 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.

- 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.

Locations and Contacts

Site Reference ID/Investigator# 22062, Linkoping 581 85, Sweden

Site Reference ID/Investigator# 14022, Lund 22185, Sweden

Site Reference ID/Investigator# 14023, Malmo 20502, Sweden

Site Reference ID/Investigator# 14301, Oskarstroem 31392, Sweden

Site Reference ID/Investigator# 20241, Skoevde 54185, Sweden

Site Reference ID/Investigator# 14021, Stockholm SE-141 86, Sweden

Site Reference ID/Investigator# 4918, Stockholm 171 76, Sweden

Site Reference ID/Investigator# 14302, Uppsala 75185, Sweden

Additional Information

Starting date: January 2009
Last updated: November 21, 2013

Page last updated: August 23, 2015

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