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Tumor Necrosis Factor Inhibitors

Patients received tocilizumab 4 mg/kg intravenously every 4 weeks for 24 weeks.

Patients received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks.

Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.

Tocilizumab

Placebo

Clinical Trials

This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all patients.

This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.

A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy

A Randomized, Double-blind, Parallel Group Placebo-controlled Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab (TCZ) Versus Placebo in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy

ASAS20 was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 10 units on a 0-100 visual analog scale (VAS) from Baseline to Week 12 in 3 of 4 domains: 1-Patient global assessment (with extremes labelled none and severe), 2-Pain assessment (average total and nocturnal pain scores with extremes labelled no pain and most severe pain), 3-Function (represented by the Bath Ankylosing Spondylitis (BAS) Functional Index \[BASFI\] average of 10 questions regarding ability to perform specific tasks with extremes labelled easy and impossible), and 4-Inflammation (average of the last 2 questions on the 6-question BAS Disease Activity Index \[BASDAI\] concerning morning stiffness intensity with extremes labelled none and very severe and duration between 0 and 2 or more hours); and the absence of deterioration (of at least 20% and absolute change of at least 10 units on a 0-100 mm scale) in the remaining domain.

Hoffmann-La Roche

Safety population: Patients who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment. Patients were assigned to groups as treated; 95 patients in the combined tocilizumab groups, including 4 patients randomized to placebo who received escape therapy of 8 mg/kg tocilizumab at Week 16.

Patients randomized to tocilizumab who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks for 24 weeks and patients randomized to placebo who switched or escaped to tocilizumab treatment.

Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.

Tocilizumab 4 or 8 mg/kg

Total

Age Continuous

Sex: Female, Male

Medical Communications

Intent-to-treat population: All randomized patients who received at least 1 dose of treatment. The analysis only included assessments while patients were receiving double-blind treatment and that occurred prior to withdrawal or the date when all patients were unblinded (15 Jul 2011). Patients who withdrew or escaped were considered non-responders.

Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12

Overall Study

Nutritional and Metabolic Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Obesity

Arthritis, Rheumatoid

Arthritis, Psoriatic

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Antirheumatic Agents

Dermatologic Agents

Gastrointestinal Agents

Adalimumab

Infliximab

Patients with Rheumatoid Artritis, Psoriatic Arthritis, Anchylosing Spondylitis starting treament with infliximab or adalimumab

Karen B Lauridsen, MD

Lene Dreyer, MD, Prof.

The aim of the study is to explore whether the influence of gender, tobacco smoking and obesity on treatment response in tumor necrosis factor inhibitors (TNFIs) can be explained by high degree of inflammation, human leucocyte antigen (HLA) type, autoantibodies, TNF and TNFI concentration and presence of ADA.

Tumor necrosis factor inhibitors (TNFIs) have been uses with success since 1999 in Denmark in treatment of various inflammatory diseases, eg. rheumatoid arthritis (RA), Chrohn's disease, psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

TNFIs block a central cytokine in the inflammatory process, tumor necrosis factor (TNF).

Because the drugs are large proteins, they are prone to trigger an immune response and elicit anti-drug antibodies(ADA).

Epidemiologic studies have revealed that groups of patients (women, tobacco smokers, obese patients) with inflammatory rheumatic diseases have a lower response to TNFIs. The reasons for this are not fully elucidated. The hypothesis is that immunogenicity and changed pharmacokinetic of TNFI are causes of the inferior response.

The investigators will carry out a prospective clinical studies of 120 arthritis patients (RA, PsA and AS) initiating treatment with adalimumab or infliximab. The patients will be followed for 12 months and will be registered in DANBIO as normal praxis. Blood samples will be collected at baseline, 2, 4 and 12 months or at termination of the treatment.

Genotypes, autoantibodies, inflammation markers, TNFI and ADA will be measured.

The aim of the study is to explore:

A: If differences between men and women with respect to different markers of inflammation, human leucocyte antigen (HLA), autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among women.

B: If differences between smokers and non-smokers with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among patients with arthritis who smoke tobacco.

C: If differences between obese and normal weight patients with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment.

The study will contribute with new knowledge, which hopefully can make the treatment more personalized and efficient.

EDTA Whole Blood EDTA-plasma, EDTA-buffy coat, serum.

Characterization of Immunogenicity of TNF Inhibitors in Arthritis Patients With Poorer Treatment Response.

Characterization of Immunogenicity of Tumor Necrosis Factor Inhibitors in Arthritis Patients With Poorer Treatment Response Due to Gender, Obesity and Smoking Status.

Changes in disease activity score according to the diagnose. A reduction in the disease activity score indicates a good treatment response.

* Disease Activity Score 28 joints with C-reactive protein (DAS28-CRP)
* Disease Activity in Psoriasis Arthritis (DAPSA)
* Ankylosing Spondylitis Activity Score (ASDAS)
* Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
* Bath Ankylosin Spondylitis Functional Index (BASFI)

Antibodies directed against infliximab or adalimumab. Concentration of anti-drug-antibodies

Plasma koncentration of infliximab or adalimumab

Genomic determination of Human Leucocyte antigens

Aalborg University Hospital

Principal Investigator

Group of Tai Chi intervention include 18 patients with AS. Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi. The training will take 60 minutes, 2 days a week and 10 weeks in total.

Conventional exercises are stretching for the cervical, thoracic and lumbar flexibility, shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for abdominal, back and proximal muscles. The exercises that will be taught in detail to each stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week. The patients will be inspected and controlled by monthly controls.

Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques for patients with rheumatic diseases.

Tai Chi (exercise)

Ayse Ayan, Dr

Ankylosing Spondylitis (AS) is a chronic inflammatory rheumatic disease that causes a decrease in physical activity, fatigue, sleep problems and psychological consequences such as depression, anxiety and stress by primarily affecting the sacroiliac joint and spine. The aim of the treatment of AS is to prevent the hardness and flexion deformity associated with the disease; to maintain the patient's healthy psychological and physical condition. The first step in the treatment of AS; Pharmacological treatment of NSAIDs or Anti-TNFs along with exercise. Exercise, especially pain and immobility symptoms control provides patients with disease is an advantage.

Tai Chi Chuan or Taiji is a traditional Chinese exercise method that has been applied for more than 300 years. Exercises based on Chinese medicine and martial arts. It is a combination of physical exercise and relaxation techniques and is used to improve the mental and physical health of individuals. In literature, balance, strength, coordination, postural control, agility, reaction time, flexibility has attracted attention for developing such factors. In addition, it increases muscle strength in elderly people and decreases the risk of falling; Rheumatoid arthritis and Osteoarthritis-related symptoms have been reported to improve in a positive way. In the literature, there is only one study examining the efficacy of Tai Chi in AS patients. According to the results of this study, Tai Chi has a positive effect on disease activity and flexibility of patients with AS.

Although there is consensus on exercise role in the treatment of AS, when the literature is reviewed, it is seen that the strict and definite guidelines on the type and frequency of exercises are not yet described. There is no defined protocol for which specific exercise is appropriate in AS. The literature considers that more information is needed on the various physical therapy programs related to intensity, frequency and duration to determine the most appropriate activity for the disease.

The aim of this study was to investigate the effect of Tai Chi exercises on functionality, disease activity, functional exercise capacity, spinal mobility, lower extremity strength and quality of life in AS patients with biological agents.

At least 36 AS patients followed-up by Antalya Training and Research Hospital, who are receiving Anti-TNF therapy and who do not have any other disease affecting their functions will be included in the study. There were 18 patients in the conventional treatment group and 18 patients in the Tai Chi group.

After the demographic data of AS patients were recorded, Bath AS Disease Activity Index (BASDAI), Bath AS Disease Activity Index (BASFI) and Bath AS Metrology Index (BASMI), respectively, to be used for activity and basic measurements of the disease, 6 minutes walking test to measure aerobic capacity , Cognitive Exercise Therapy Approach Scale and Ankylosing Spondylitis Quality of Life Questionnaire to be used for quality of life, 30 second sit-down test to evaluate the lower extremity strength. In addition, 10-20 ml (1-2 tubes) of blood will be taken from the patient's arm, the amount of substances such as erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) in the blood will be measured. Patients will not be charged any fee related to this process. Evaluation methods will be applied to the cases before the start of training and after the completion of the training.

For the training, both patient groups were randomly divided into two groups: the first group was treated with conventional treatment and the second group with Tai Chi training. The training will last 10 weeks.

Conventional treatment; stretching for the cervical, thoracic and lumbar flexibility, shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for abdominal, back and proximal muscles. The exercises that will be taught in detail to each stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week. The patients will be inspected and controlled by monthly controls.

Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi. The training will take 60 minutes, 2 days a week and 10 weeks in total.

Patients with Ankylosing spondylitis receiving anti-tnf alpha therapy

Effects of Tai Chi in Patients With Ankylosing Spondylitis Receiving Anti-tumor Necrosis Factor Alpha Therapy

Tai Chi in Patients With Ankylosing Spondylitis

We will use Statistical package for the social sciences (SPSS) for participant data after interventions

This self-assessment instrument was designed by a team of medical professionals in conjunction with patients, and consists of 8 specific questions regarding function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). Higher scores show poor functionality.

The index, designed by a multidisciplinary team with input from patients, consists of six 10 cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10. Higher scores show poor disease activity.

İt is for quantify the mobility of the axial skeleton in ankylosing spondylitis (AS) patients and allow objective assessment of clinically significant changes in spinal movement.It is included of clinical measures of cervical rotation, tragus to wall distance, lumbar flexion, lumbar side flexion, and intermalleolar distance.Each item is scored from 0-10 based on individually defined cut points. Ranges are given as cervical rotation (\>85.0° to ≤8.5°), tragus to wall (\<10 cm to ≥38 cm), lumbar flexion (\>7.0 cm to ≤0.7 cm), lumbar side flexion (\>20.0 cm to \<1.2 cm), and intermalleolar distance (≥120 cm to \<30 cm). Higher scores show poor spinal mobility.

It is purpose to measure the impact of ankylosing spondylitis (AS) on health-related quality of life from the patient's perspective.The questionnaire includes items related to the impact of disease on sleep, mood, motivation, coping, activities of daily living, independence, relationships, and social life. It is included 18 items.Dichotomous responses, with 0 scored for a "no" and 1 scored for a "yes" for each item. Total score is the sum of the individual responses.Score range is 0-18, with higher scores reflecting greater impairment of health-related quality of life.

The maximum distance that individuals can walk in a 30-meter straight and inclined corridor for 6 minutes is recorded. Higher distances show better aerobic capacity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy	NCT01209689	Spondylitis, An...	Tocilizumab Placebo	18 Years -	Hoffmann-La Roche
A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy	NCT01209689	Spondylitis, An...	Tocilizumab Placebo	18 Years -	Hoffmann-La Roche
Characterization of Immunogenicity of TNF Inhibitors in Arthritis Patients With Poorer Treatment Response.	NCT04731831	Arthritis, Rheu... Arthritis, Psor... Spondylitis, An...		18 Years -	Aalborg University Hospital
Effects of Tai Chi in Patients With Ankylosing Spondylitis Receiving Anti-tumor Necrosis Factor Alpha Therapy	NCT03807180	Spondylitis, An...	Tai Chi (exerci...	18 Years - 65 Years	Pamukkale University

Spots Global Cancer Trial Database for spondylitis, ankylosing