Phase 4
Completed N=33
A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00808509 ↗
Enrolled (actual)
33
Serious AEs
14.3%
Results posted
Nov 2013
Primary outcomePrimary: Percentage of Participants in Remission at Week 28 — 87.5; 18.8 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Remission at Week 28 |
87.5; 18.8 | — |
| PRIMARY Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2) |
87.5; 20.0 | — |
| SECONDARY Percentage of Participants in Remission at Week 52 |
81.3; 12.5 | — |
| SECONDARY Percentage of Participants in Remission at Week 52 (FAS2) |
81.3; 13.3 | — |
| SECONDARY Number of Participants With a Flare |
2; 3; 0; 3; 4; 4 | — |
| SECONDARY Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare |
33.3; 0; 22.2; 11.1 | — |
| SECONDARY Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare |
66.7; 0; 22.2; 0 | — |
| SECONDARY Health Assessment Questionnaire (HAQ) Total Score by Visit |
0.35; 0.39; 0.35; 0.42; 0.34; 0.39 | — |
| SECONDARY European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit |
12; 13; 4; 2; 0; 0 | — |
| SECONDARY European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit |
15; 16; 1; 0; 0; 0 | — |
| SECONDARY European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit |
14; 15; 2; 1; 0; 0 | — |
| SECONDARY European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit |
6; 3; 10; 13; 0; 0 | — |
| SECONDARY European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit |
14; 12; 2; 4; 0; 0 | — |
| SECONDARY European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit |
88.2; 89.9; 85.6; 83.2; 88.4; 82.8 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit |
45.2; 42.5; 45.3; 43.6; 46.9; 44.9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis |
2; 1; 10; 7; 4; 8 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Get Very Stiff at Work |
1; 0; 11; 7; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage |
2; 1; 10; 6; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare |
3; 0; 9; 7; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem |
2; 1; 10; 6; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work |
6; 4; 6; 3; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower |
3; 1; 9; 6; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work |
3; 1; 9; 6; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working |
2; 1; 10; 6; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work |
0; 0; 12; 7; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do |
5; 2; 7; 5; 4; 9 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI): Currently Employed |
10; 7; 5; 8; 1; 1 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI): Hours Missed From Work |
1.1; 1.1; 1.4; 0.0; 1.4; 6.0 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons |
3.8; 5.0; 11.9; 8.3; 3.2; 3.8 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI): Hours Worked |
31.5; 31.1; 29.8; 38.3; 34.7; 32.7 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI): Work Productivity |
0.8; 2.1; 1.3; 1.3; 1.0; 1.0 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI): Daily Activities |
1.6; 1.5; 1.5; 1.8; 1.9; 1.6 | — |
| SECONDARY Change From Baseline in Radiological Modified Total Sharp Score |
0.1; -0.8; -2.4; -7.2 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT00808509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.