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Canakinumab for Treatment of Adult-onset Still's Disease (CONSIDER)

Primary Purpose

Adult-Onset Still´s Disease

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Canakinumab

Placebo

About this trial

This is an interventional treatment trial for Adult-Onset Still´s Disease focused on measuring Adult-Onset Still´s Disease, Canakinumab, Joint involvement, AOSD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written and signed consent from the participant to take part in the study
Men and women aged ≥ 18 years and ≤ 75 years
Fulfilment of AOSD classification criteria (according to Yamaguchi et al, J. Rheumatology, 1992)
Disease activity based on Disease Activity Score 28 (DAS28) of ≥3.2 at screening
At least 4 painful and 4 swollen joints at screening and baseline (of the 28 joints according to DAS28)
If undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), stable dose for at least 4 weeks prior to randomisation
If undergoing treatment with glucocorticoids, stable dose of ≤10 milligrams per day (mg/day) (prednisolone or equivalent) for at least 4 weeks prior to randomisation
If undergoing treatment with conventional disease-modifying anti-rheumatic drugs (DMARD), stable dose for at least 3 months prior to randomisation
Normalisation period for biological DMARDS (anakinra 1 week, etanercept 1 month, adalimumab and certolizumab 2 months, infliximab, golimumab, abatacept and tocilizumab 3 months, rituximab 9 months, canakinumab 6 months) prior to randomisation
In participants of reproductive age, use of an effective method of contraception as well as negative pregnancy test prior to the study commencing.

Exclusion Criteria:

Previous treatment with the study drug with repeated administration of canakinumab
Intraarticular or intravenous administration of glucocorticoids within 4 weeks prior to the baseline or use of narcotic analgesics except for analgesics permitted within the framework of the investigation (codeine and tramadol)
Presence of another, serious chronic-inflammatory disease
Positive hepatitis B antigen (HBsAg), hepatitis C antibodies and/or human immunodeficiency virus (HIV) antibodies.
Presence of a relevant, active infection or other diseases, which entail a tendency towards infection
Positive screening for latent tuberculosis, in accordance with usual local practice
Raised liver count (raised bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3-fold the normal range)
Serum-creatinine concentration >1.5 milligrams per deciliter (mg/dL)
Inadequate haematological findings (hemoglobin [Hb] ≤ 10 grams per deciliter (g/dL), neutrophils ≤2,500/microliter (µl) and thrombocytes ≤100,000/µl)
Simultaneous participation in any other interventional clinical study within the last 30 days preceding the commencement of the study
History of neoplasia with the exception of a curatively treated non-melanoma skin tumour or carcinoma of the cervix treated in situ without any indication of recurrence within the last 10 years
Relevant cardiac or pulmonary disorders
Severe intercurrent neurological or psychiatric disorders
Macrophage activation syndrome (MAS) as part of previous treatment with IL-1 blockade (e.g. anakinra, rilonacept)
Vaccination with a live vaccine within 3 months before the baseline
Alcohol or drug abuse in the past 12 months
≥400 milliliter (mL) donation of blood or loss up to 8 weeks before the baseline
Pregnancy or breast-feeding
Commitment of the patient to an institution at the direction of an authority or court

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Canakinumab

Placebo

Arm Description

Participants received canakinumab 4 mg/kg up to a maximum of 300 mg subcutaneous (SC) injection, once in morning on Day 0, Weeks 4, 8, and 12 in Part I of the core study. Participants with response (change in DAS score > 1.2 at Week 12) continued to receive same dose of canakinumab in Part II for Weeks 12, 16, and 20. Participants who had remission (change in DAS score > 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) entered Long-term extension (LTE) phase and received same dose of canakinumab at Weeks 24 and 28, which was down titrated to 2 mg/kg if applicable from Week 28 up to Month 27.

Participants received placebo, SC injection, once in morning on Day 0, Weeks 4, 8, and 12 in Part I of the core study. Participants with response (change in DAS score > 1.2 at Week 12) continued to receive placebo at Weeks 12, 16, and 20. Non-responders (who had change in DAS score ≤ 1.2) were unblinded to receive canakinumab 4 mg/kg (up to 300 mg maximum), SC injection, at Weeks 12, 16, and 20. Participants who had remission (change in DAS score > 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) entered Long-term extension (LTE) phase and received same dose of canakinumab at Weeks 24 and 28, which was down titrated to 2 mg/kg if applicable from Week 28 up to Month 27.

Outcomes

Primary Outcome Measures

Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12

Responders included participants with change in disease activity score based on 28 joint counts and ESR (DAS28) score > 1.2. The DAS28 score index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and the erythrocyte sedimentation rate (ESR) value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value < 2.6 = disease remission.

Secondary Outcome Measures

Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score

The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and ESR value.Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value < 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Least squares (LS) mean was calculated by mixed linear model for repeated measures (MMRM) analyses.

Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score

The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value < 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC)

The 68 TJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no tender joint) to 68 (all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC)

The 66 SJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no swollen joint) to 66 (all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. A negative change in Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in the 28 TJC

A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in the 28 SJC

A total of 28 joints were assessed for swelling. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP

A negative change from Baseline in CRP level indicates an improvement. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR

A negative change from Baseline in ESR level indicates an improvement. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in Serum Ferritin Level at Week 12

LS mean was calculated by MMRM analyses.

Core Study Part I: Percentage of Responders With Fever Episodes

Fever is defined as an oral or rectal body temperature greater than 38 degrees Celsius (°C).

Core Study Part I: CFB in ACR Component: Physician's Global Assessment of Disease Activity Score

The physician's global assessment of disease activity was assessed using a numerical rating scale of 0-10 where 0= no disease activity and 10= activity to maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Disease Activity Score

The participant's global assessment of disease activity was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Pain Score

The participant's global assessment of pain was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.

Core Study Part I: Percentage of Responders With American College of Rheumatology Response of 20 (ACR20)

ACR20 response was defined as a ≥ 20% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.

Core Study Part I: Percentage of Responders With ACR30

ACR30 response was defined as a ≥ 30% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.

Core Study Part I: Percentage of Responders With Modified ACR30

A participant was considered responder if he/she had achieved the incidence of modified adapted response (ACR30 criteria) of at least a 30% improvement in no intermittent fever and had at least 30% improvement in at least 6 of the following 7 measures: tender and swollen 68-joint counts, participant's assessment of pain, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's functional capacity (HAQ-DI score) and acute phase reactant- ESR. Participant were modified ACR30 responders at a given post-randomization visit if they satisfied the modified ACR30 criteria, respectively.

Core Study Part I: Percentage of Responders With ACR50

ACR50 response was defined as a ≥ 50% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.

Core Study Part I: Percentage of Responders With ACR70

ACR70 response was defined as a ≥ 70% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.

Core Study Part I: Percentage of Responders With ACR90

ACR90 response was defined as a ≥ 90% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.

Core Study Part I: Percentage of Responders With European League Against Rheumatism (EULAR) Response

EULAR response is based on DAS28-ESR and DAS28-CRP scores. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, subject global assessment of disease activity score, and ESR or CRP value. A DAS28-CRP or ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value < 2.6 = disease remission. EULAR response has 3 categories: EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2 or EULAR No response: DAS28 >5.1 or a change from Baseline < -0.6 to ≤ -1.2.

Core Study Part I: Percentage of Responders Achieving Low Disease Activity (LDA)

Percentage of responders were defined as the participants who achieved LDA (DAS28 score < 3.2) at Week 12. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR or CRP value. Total score ranged between 0-10. A DAS28 score greater than 5.1 implies high disease activity, equal to or less than 3.2 low disease activity, and less than 2.6 remissions.

Core Study Part I: Percentage of Responders Achieving Disease Remission and Extended Disease Remission

Participants with disease remission: LDA (DAS28 score< 2.6). The DAS28 index is a composite score of weighted components including both 28 TJC an SJC, participant global assessment of disease activity score, and ESR or CRP value. A DAS28 score greater than 5.1: high disease activity, ≤ 3.2: low disease activity, and less than 2.6: remission. Extended remission criteria included DAS28 < 2.6 and no signs of systemic activity for up to two consecutive study visits till Week 12 defined as any of Yamaguchi´s primary classification criteria for AOSD which included fever attacks at 39 °C for more than a week, arthralgia, salmon red, maculate, urticarial or maculo-papular rash and leukocytosis (white blood cells increase) of > 10000/cubic millimeters (mm^3) with > 80% neutrophils.

Core Study Part I: Change in Joint Mobility (Degrees of Motion) Assessed by Neutral Zero Method

Number of joints with limitation of motion according to neutral zero method was assessed which included mobility of joints (elbows, wrists, shoulder joints, hip joints, knee joints, and upper ankle joints) within the reference range/degree. Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from Baseline. A negative change score indicates improvement. LS mean was calculated by MMRM analyses.

Core Study Part I: CFB in Medical Outcome Short Form (SF-36) Health Survey Score

The SF-36 determines overall quality of life assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 contribute to physical component summary score (PCS). Items 5-8 contribute to mental component summary score (MCS). Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Positive numbers indicate improvement from Baseline. LS mean was calculated by MMRM analyses.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. AEs include symptoms of illnesses, as well as every unfavourable and unintended reaction. SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.

Full Information

NCT ID

NCT02204293

First Posted

July 29, 2014

Last Updated

July 17, 2020

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT02204293

Brief Title

Canakinumab for Treatment of Adult-onset Still's Disease

Acronym

CONSIDER

Official Title

Study Protocol for a Multi-Centre, Placebo-Controlled Phase II Study of Canakinumab for the Treatment of Adult-onset Still's Disease (AOSD) Including an Open-label Long Term Extension

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Terminated

Why Stopped

Recruitment issues due to marketing authorization of study drug

Study Start Date

June 21, 2012 (Actual)

Primary Completion Date

May 5, 2018 (Actual)

Study Completion Date

May 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this trial is to investigate the efficacy of the treatment with canakinumab in participants with Adult-onset Still's Disease (AOSD) and active joint involvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult-Onset Still´s Disease

Keywords

Adult-Onset Still´s Disease, Canakinumab, Joint involvement, AOSD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Canakinumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Canakinumab

Other Intervention Name(s)

Ilaris

Intervention Description

Canakinumab, single-dose 4 mg/kg up to 300 mg administered subcutaneously.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo administered subcutaneously.

Primary Outcome Measure Information:

Title

Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score

Description

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score

Description

The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value < 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. LS mean was calculated by MMRM analyses.

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC)

Description

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC)

Description

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in the 28 TJC

Description

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in the 28 SJC

Description

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP

Description

A negative change from Baseline in CRP level indicates an improvement. LS mean was calculated by MMRM analyses.

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR

Description

A negative change from Baseline in ESR level indicates an improvement. LS mean was calculated by MMRM analyses.

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in Serum Ferritin Level at Week 12

Description

LS mean was calculated by MMRM analyses.

Time Frame

Week 12

Title

Core Study Part I: Percentage of Responders With Fever Episodes

Description

Fever is defined as an oral or rectal body temperature greater than 38 degrees Celsius (°C).

Time Frame

Week 12

Title

Core Study Part I: CFB in ACR Component: Physician's Global Assessment of Disease Activity Score

Description

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Disease Activity Score

Description

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Pain Score

Description

Time Frame

Baseline, Weeks 4, 8 and 12

Title

Core Study Part I: CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

Description

Time Frame

Baseline, Week 12

Title

Core Study Part I: Percentage of Responders With American College of Rheumatology Response of 20 (ACR20)

Description

Time Frame

Baseline, Week 12

Title

Core Study Part I: Percentage of Responders With ACR30

Description

Time Frame

Baseline, Week 12

Title

Core Study Part I: Percentage of Responders With Modified ACR30

Description

Time Frame

Baseline, Week 12

Title

Core Study Part I: Percentage of Responders With ACR50

Description

Time Frame

Baseline, Week 12

Title

Core Study Part I: Percentage of Responders With ACR70

Description

Time Frame

Baseline, Week 12

Title

Core Study Part I: Percentage of Responders With ACR90

Description

Time Frame

Baseline, Week 12

Title

Core Study Part I: Percentage of Responders With European League Against Rheumatism (EULAR) Response

Description

Time Frame

Baseline, Week 12

Title

Core Study Part I: Percentage of Responders Achieving Low Disease Activity (LDA)

Description

Time Frame

Week 12

Title

Core Study Part I: Percentage of Responders Achieving Disease Remission and Extended Disease Remission

Description

Time Frame

Week 12

Title

Core Study Part I: Change in Joint Mobility (Degrees of Motion) Assessed by Neutral Zero Method

Description

Time Frame

Baseline, Week 12

Title

Core Study Part I: CFB in Medical Outcome Short Form (SF-36) Health Survey Score

Description

Time Frame

Baseline, Week 12

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Up to Month 27

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written and signed consent from the participant to take part in the study Men and women aged ≥ 18 years and ≤ 75 years Fulfilment of AOSD classification criteria (according to Yamaguchi et al, J. Rheumatology, 1992) Disease activity based on Disease Activity Score 28 (DAS28) of ≥3.2 at screening At least 4 painful and 4 swollen joints at screening and baseline (of the 28 joints according to DAS28) If undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), stable dose for at least 4 weeks prior to randomisation If undergoing treatment with glucocorticoids, stable dose of ≤10 milligrams per day (mg/day) (prednisolone or equivalent) for at least 4 weeks prior to randomisation If undergoing treatment with conventional disease-modifying anti-rheumatic drugs (DMARD), stable dose for at least 3 months prior to randomisation Normalisation period for biological DMARDS (anakinra 1 week, etanercept 1 month, adalimumab and certolizumab 2 months, infliximab, golimumab, abatacept and tocilizumab 3 months, rituximab 9 months, canakinumab 6 months) prior to randomisation In participants of reproductive age, use of an effective method of contraception as well as negative pregnancy test prior to the study commencing. Exclusion Criteria: Previous treatment with the study drug with repeated administration of canakinumab Intraarticular or intravenous administration of glucocorticoids within 4 weeks prior to the baseline or use of narcotic analgesics except for analgesics permitted within the framework of the investigation (codeine and tramadol) Presence of another, serious chronic-inflammatory disease Positive hepatitis B antigen (HBsAg), hepatitis C antibodies and/or human immunodeficiency virus (HIV) antibodies. Presence of a relevant, active infection or other diseases, which entail a tendency towards infection Positive screening for latent tuberculosis, in accordance with usual local practice Raised liver count (raised bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3-fold the normal range) Serum-creatinine concentration >1.5 milligrams per deciliter (mg/dL) Inadequate haematological findings (hemoglobin [Hb] ≤ 10 grams per deciliter (g/dL), neutrophils ≤2,500/microliter (µl) and thrombocytes ≤100,000/µl) Simultaneous participation in any other interventional clinical study within the last 30 days preceding the commencement of the study History of neoplasia with the exception of a curatively treated non-melanoma skin tumour or carcinoma of the cervix treated in situ without any indication of recurrence within the last 10 years Relevant cardiac or pulmonary disorders Severe intercurrent neurological or psychiatric disorders Macrophage activation syndrome (MAS) as part of previous treatment with IL-1 blockade (e.g. anakinra, rilonacept) Vaccination with a live vaccine within 3 months before the baseline Alcohol or drug abuse in the past 12 months ≥400 milliliter (mL) donation of blood or loss up to 8 weeks before the baseline Pregnancy or breast-feeding Commitment of the patient to an institution at the direction of an authority or court

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eugen Feist, Prof. Dr.

Organizational Affiliation

Charité University Berlin Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charité Campus Mitte

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Immanuel Krankenhaus Berlin

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Universität Erlangen

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Kliniken Essen-Süd/Krankenhaus St. Josef

City

Essen

ZIP/Postal Code

45239

Country

Germany

Facility Name

Universitätsklinikum der J.W. Goethe-Universität Frankfurt

City

Frankfurt a. M.

ZIP/Postal Code

60590

Country

Germany

Facility Name

Asklepios Klinikum Hamburg Altona

City

Hamburg

ZIP/Postal Code

22763

Country

Germany

Facility Name

Medizinische Hochschule Hannover

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Universitätsklinikum Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Universitätskrankenhaus Schleswig Holstein

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Med. Klinik I für Innere Medizin Köln

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Klinikum der Universität München

City

München

ZIP/Postal Code

80336

Country

Germany

Facility Name

Klinikum Südstadt Rostock

City

Rostock

ZIP/Postal Code

18059

Country

Germany

Facility Name

Universitätsklinikum Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Fachkrankenhaus

City

Vogelsang

ZIP/Postal Code

39245

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26589963

Citation

Nirmala N, Brachat A, Feist E, Blank N, Specker C, Witt M, Zernicke J, Martini A, Junge G. Gene-expression analysis of adult-onset Still's disease and systemic juvenile idiopathic arthritis is consistent with a continuum of a single disease entity. Pediatr Rheumatol Online J. 2015 Nov 20;13:50. doi: 10.1186/s12969-015-0047-3.

Results Reference

derived

Links:

URL

http://ard.bmj.com/content/early/2020/05/13/annrheumdis-2020-217155

Description

Related Info

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Canakinumab for Treatment of Adult-onset Still's Disease

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Canakinumab for Treatment of Adult-onset Still's Disease (CONSIDER)

Adult-Onset Still´s Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial