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Table 1 Outcome variables and definitions

From: Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial

Outcomes

Measures

Time frame

Proportion of patients who are at acceptable therapeutic goal (SER)*

Acceptable therapeutic goal (SER)*

1 year post-randomization (primary)

- BASDAI <4

End of study (secondary)

- Physician GA <4

- Patient GA <4

- Nocturnal axial pain <4

Proportion of patients who are at ideal therapeutic goal (SER)*

Ideal therapeutic goal (SER)*:

1 year post-randomization (key secondary)

- BASDAI ≤2

- Physician GA ≤2

End of study

- Patient GA ≤2

Proportion of patients who are in remission (ASDAS-C)

ASDAS-C <1.3

1 and 2 years post-randomization, End of study

Proportion of patients with disease relapse (SER)*

Disease relapse (SER)*

1 and 2 years post-randomization, End of study

Time to clinical relapse (SER)*

- BASDAI ≥4

During study follow-up

- Physician GA ≥4 AND one or more of 3:

- Patient GA ≥ 4

- Nocturnal axial pain ≥ 4

- Increased CRP and/or ESR

Proportion of patients with disease relapse (ASDAS-C)

ASDAS-C ≥2.1

1 and 2 years post-randomization, End of study

Time to clinical relapse (ASDAS-C)*

 

During study follow-up

Proportion of patients with clinical relapse (BASDAI/Patient GA)

Clinical relapse

1 and 2 years post-randomization, End of study

Time to clinical relapse (BASDAI/Patient GA)*

- BASDAI increase by 20 % or by 2/10 points AND

During study follow-up

- Patient GA increased by 20 % or 2/10 points

Proportion of patients withdrawn due to requirement for changes in anti-TNFtreatment.

Unplanned change of the assigned anti-TNF regimen decided by the investigator due to lack of efficacy, safety issues or treatment-related reasons.

End of study

NSAIDs use

Dougados criteria (42)

1 and 2 years post-randomization, End of study

Patient function (BASFI)

Change from baseline in the BASFI scores

1 and 2 years post-randomization, End of study

Ankylosing Spondylitis Quality of Life (ASQoL)

Change from baseline in the ASQoL (Spanish validated version of ASQoL (41))

1 and 2 years post-randomization, End of study

Proportion of patients with any related severe adverse event

≥1 severe adverse events with causality assessment at least possibly related to anti-TNF

 

Time to related severe adverse event

Number of days from randomization to first symptom of a severe adverse event with causality assessment at least possibly related to anti-TNF

 

Radiological progression

mSASSS

 
  1. *According to SER consensus [27]. SER: Sociedad Española de Reumatología (Spanish Society of Rheumatology). BASDAI: Bath Ankylosing Spondylitis Disease Activity Index [49], which is calculated as {A + B + C + D + [(E + F) / 2]}/5 where A to E are 6 Visual Analog Scales (VAS) rated 0 (best) to 10 (worst) assessing (A) fatigue, (B) axial skeletal pain, (C) peripheral joint pain, (D) pain on contact or pressure, (E) intensity of morning stiffness and (F) duration of morning stiffness. Physician GA: Physician Global Assessment of disease activity by VAS rated 0 (best) to 10 (worst). Patient GA: Patient Global Assessment of disease activity by VAS rated 0 (best) to 10 (worst). ASDAS-C: Ankylosing Spondylitis Disease Activity Score [50], which is calculated as (0.12 x back pain) + (0.06 x duration of morning stiffness) + (0.11 x patient GA) + (0.07 x peripheral pain/swelling) + (0.58 x Ln(CRP + 1)); if CRP is not available but ESR is available, the last term is changed by (0.29 x √(ESR)). BASFI: Bath Ankylosing Spondylitis Functional Index [51] mSASSS: modified Stoke Ankylosing Spondylitis Spine Score [28]