To see whether for patients with established rheumatoid arthritis that have already achieved a good response to Tumour Necrosis Factor Inhibitor (TNF inhibitor) treatment, whether the treatment be tapered to a minimum dose without affecting the control of disease activity.

Optimising Treatment With Tumour Necrosis Factor Inhibitors In Rheumatoid Arthritis: Is Dose Tapering Practical In Good Responders? A “Proof Of Principle” And Exploratory Trial. (OPTTIRA) - OPTTIRA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020738-24-GB

Enrollment

Registered

2010-08-17

Start date

2010-10-12

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with established Rheumatoid arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Enbrel pre-filled pen Product Name: Etanercept Pharmaceutical Form: Solution for injection INN or Proposed INN: etanercept C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. RA by the criteria of the American College of Rheumatology b. Etanercept or adalimumab treatment for at least 6 months (a break of up to 4 consecutive weeks is permitted). c. Taking at least one DMARD from the list in the study protocol d. Stable clinical response for at least 3 months (one DAS28 score of at least 3.2; no changes in DAS28 >0.6 in the last 3 months) e. Patient considers he or she has achieved a suitable response to TNF inhibitors f. Supervising rheumatologist considers further improvements are unlikely on the patient’s current treatment regimen. g. At least 18 years of age h. Willing and able to give informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 99 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 99

Exclusion criteria

Exclusion criteria: a. Serious concurrent illness (e.g. terminal cancer) b. Prednisolone at more than 10mg daily (for doses > 10mg daily, a 4 week washout period is required) c. Recently received IM/IA steroids (4 weeks washout required) d. Participation in another clinical trial (other than observational or lifestyle studies and registries) concurrently or within 12 weeks of screening e. Pregnancy, breast-feeding or women of child-bearing potential not using adequate contraception

Design outcomes

Primary

Measure	Time frame
Main Objective: The study investigates whether in it is possible to reduce the dose of or even stop TNF-inhibitors without adversely affecting the control of this disease. This will be assessed by looking at: a. The risk of disease flares (using the disease activity score with a 28 tender and swollen joint count (DAS28). An increase of disease activity score (DAS28) of 0.6 or more represents adversely affecting disease control and is considered a flare) b. If flares are reversed by reverting to the original TNF inhibitor dosage c. If either tapering group show worse key RA assessments including disease activity (DAS28) and disability as measured by health assessment questionnaire (HAQ) scores d. Structural damage (plain hand and fe ; Secondary Objective: The secondary objectives are to investigate the effects of TNF-inhibitor tapering on: 1. The individual components of the DAS28 scores (tender and swollen joint counts, patient global assessment of health and Erythrocyte Sedimentation rate (ESR)) and associated disease activity indices Simple disease activity score (SDAI) and clinical disease activity score (CDAI) 2. Patient Quality of life (Health Assessment Questionnaire (HAQ) and EuroQol scores) 3. Adverse events 4. Radiographic progression (Plain x-rays of the hands and feet) 5. Serum, immunological and gene expression profiles ; Primary end point(s): The primary outcome measure will be the development of flares, defined as an increase in DAS28 scores = 0.6 To ensure such changes in DAS28 represent a genuine flare in RA and are not due to unrelated events, we will take additional criteria: 1. It must include an increase in the swollen joint count 2. It must be present on two occasions at least one week apart	—

Measure

Time frame

Main Objective: The study investigates whether in it is possible to reduce the dose of or even stop TNF-inhibitors without adversely affecting the control of this disease. This will be assessed by looking at: a. The risk of disease flares (using the disease activity score with a 28 tender and swollen joint count (DAS28). An increase of disease activity score (DAS28) of 0.6 or more represents adversely affecting disease control and is considered a flare) b. If flares are reversed by reverting to the original TNF inhibitor dosage c. If either tapering group show worse key RA assessments including disease activity (DAS28) and disability as measured by health assessment questionnaire (HAQ) scores d. Structural damage (plain hand and fe ; Secondary Objective: The secondary objectives are to investigate the effects of TNF-inhibitor tapering on: 1. The individual components of the DAS28 scores (tender and swollen joint counts, patient global assessment of health and Erythrocyte Sedimentation rate (ESR)) and associated disease activity indices Simple disease activity score (SDAI) and clinical disease activity score (CDAI) 2. Patient Quality of life (Health Assessment Questionnaire (HAQ) and EuroQol scores) 3. Adverse events 4. Radiographic progression (Plain x-rays of the hands and feet) 5. Serum, immunological and gene expression profiles ; Primary end point(s): The primary outcome measure will be the development of flares, defined as an increase in DAS28 scores = 0.6 To ensure such changes in DAS28 represent a genuine flare in RA and are not due to unrelated events, we will take additional criteria: 1. It must include an increase in the swollen joint count 2. It must be present on two occasions at least one week apart

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: End of trial; Secondary end point(s): DAS28 (tender and swollen joint counts, patient global (VAS), ESR) and Extended Joint Count 68/66 Simple disease activity score (SDAI) and clinical disease activity score (CDAI) [45] Health Assessment Questionnaire (HAQ) scores [46] Adverse events EuroQol scores [47] SF-36 Plain x-rays of the hands and feet scored by Larsen’s and van der Heijdi Sharpe Modified Scores (to provide preliminary data) Analysis of serum, immunological and gene expression profiles	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: End of trial; Secondary end point(s): DAS28 (tender and swollen joint counts, patient global (VAS), ESR) and Extended Joint Count 68/66 Simple disease activity score (SDAI) and clinical disease activity score (CDAI) [45] Health Assessment Questionnaire (HAQ) scores [46] Adverse events EuroQol scores [47] SF-36 Plain x-rays of the hands and feet scored by Larsen’s and van der Heijdi Sharpe Modified Scores (to provide preliminary data) Analysis of serum, immunological and gene expression profiles

—

Countries

United Kingdom

Contacts

Public ContactTrial Coordinator

King's Musculoskeletal Clinical Trials Unit

kch-tr.opttira@nhs.net02078485200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026