Who is sponsoring NCT01431638?

NCT01431638 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01431638?

Interventions in NCT01431638: Canakinumab 150mg in prefilled syringe.

What condition does NCT01431638 study?

NCT01431638 studies Acute Gouty Arthritis.

Is NCT01431638 still recruiting?

NCT01431638 is currently completed. Last updated 19 July 2021.

Are results published for NCT01431638?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-19 · How we verify

NCT01431638

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Completed Phase 3 Results posted Last updated 19 July 2021

What this trial tests

Phase 3 trial testing Canakinumab 150mg in prefilled syringe in Acute Gouty Arthritis in 397 participants. Completed in 9 May 2013.

Timeline

25 August 2011

Primary endpoint
9 May 2013

9 May 2013

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	397
Start date	25 August 2011
Primary completion	9 May 2013
Estimated completion	9 May 2013
Sites	68 locations across Canada, United States, Germany, Lithuania

Drugs / interventions tested

Canakinumab 150mg in prefilled syringe — full drug profile →

Conditions studied

Acute Gouty Arthritis — all drugs for Acute Gouty Arthritis →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 85, any sex, with Acute Gouty Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Reported Adverse Events Primary · From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	78
Canakinumab, Lyophilizate (LYO)	65
Triamcinolone Acetonide	64

Probability of New Gout Flares at End of Study Secondary · Up to Day 337

The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates.

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	65.50	54.97 – 75.81
Canakinumab, Lyophilizate (LYO)	75.42	63.82 – 85.57
Triamcinolone Acetonide	72.95	62.95 – 82.12

Number of Participant With New Flares Secondary · up to 36 weeks

The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered.

One new flare

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	35
Canakinumab, Lyophilizate (LYO)	46
Triamcinolone Acetonide	36

Two new flares

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	17
Canakinumab, Lyophilizate (LYO)	7
Triamcinolone Acetonide	26

Three new flares

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	2
Canakinumab, Lyophilizate (LYO)	0
Triamcinolone Acetonide	8

Greater (>) than three new flares

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	4
Canakinumab, Lyophilizate (LYO)	1
Triamcinolone Acetonide	3

Change From Baseline in Pain Intensity on a 5-point Likert Scale Secondary · Baseline, upto 14 days post-dose

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	-2.5	± 0.86
Canakinumab, Lyophilizate (LYO)	-2.3	± 0.97
Triamcinolone Acetonide	-2.7	± 0.83

Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time Secondary · Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose

Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.

Baseline

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	74.2	± 14.52
Canakinumab, Lyophilizate (LYO)	75.5	± 14.32
Triamcinolone Acetonide	74.3	± 14.44

6 hours post-dose

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	-12.9	± 21.03
Canakinumab, Lyophilizate (LYO)	-13.0	± 17.14
Triamcinolone Acetonide	-10.2	± 15.78

12 hours post-dose

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	-23.7	± 22.94
Canakinumab, Lyophilizate (LYO)	-26.7	± 22.09
Triamcinolone Acetonide	-23.4	± 19.87

24 hours post-dose

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	-34.9	± 24.88
Canakinumab, Lyophilizate (LYO)	-36.1	± 24.55
Triamcinolone Acetonide	-35.6	± 27.09

48 hours post-dose

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	-46.4	± 25.31
Canakinumab, Lyophilizate (LYO)	-43.8	± 24.71
Triamcinolone Acetonide	-51.1	± 26.34

72 hours post-dose

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	-55.1	± 26.97
Canakinumab, Lyophilizate (LYO)	-45.8	± 28.74
Triamcinolone Acetonide	-54.7	± 30.41

4 days post-dose

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	-55.7	± 26.91
Canakinumab, Lyophilizate (LYO)	-50.0	± 26.39
Triamcinolone Acetonide	-62.0	± 23.86

5 days post-dose

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	-59.1	± 25.99
Canakinumab, Lyophilizate (LYO)	-54.3	± 25.43
Triamcinolone Acetonide	-65.2	± 23.78

Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment Secondary · 48 weeks post-dose

Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor).

Excellent

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	50
Canakinumab, Lyophilizate (LYO)	11
Triamcinolone Acetonide	11

Good

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	17
Canakinumab, Lyophilizate (LYO)	4
Triamcinolone Acetonide	7

Acceptable

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	2
Canakinumab, Lyophilizate (LYO)	1
Triamcinolone Acetonide	5

Slight

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	3
Canakinumab, Lyophilizate (LYO)	0
Triamcinolone Acetonide	1

Poor

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	0
Canakinumab, Lyophilizate (LYO)	0
Triamcinolone Acetonide	1

Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint Secondary · Baseline, 7 days post-dose

Tenderness was measured on a 0-3 point scale: no pain, participant states that "there is pain", participant states "there is pain and winces" and participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable.

Tenderness Baseline: No Pain

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	0
Canakinumab, Lyophilizate (LYO)	0
Triamcinolone Acetonide	0

Tenderness Baseline: Pain

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	14
Canakinumab, Lyophilizate (LYO)	6
Triamcinolone Acetonide	14

Tenderness Baseline: Pain and winces

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	17
Canakinumab, Lyophilizate (LYO)	17
Triamcinolone Acetonide	20

Tenderness Baseline: Pain, winces and withdraws

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	26
Canakinumab, Lyophilizate (LYO)	26
Triamcinolone Acetonide	16

Tenderness 7 days post-dose: No Pain

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	42
Canakinumab, Lyophilizate (LYO)	36
Triamcinolone Acetonide	27

Tenderness 7 days post-dose: Pain

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	14
Canakinumab, Lyophilizate (LYO)	12
Triamcinolone Acetonide	16

Tenderness 7 days post-dose: Pain, winces

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	0
Canakinumab, Lyophilizate (LYO)	1
Triamcinolone Acetonide	5

Tenderness 7 days post-dose: Pain, winces and withdraws

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	0
Canakinumab, Lyophilizate (LYO)	0
Triamcinolone Acetonide	1

Number of Participants Responded for Physician's Global Assessment of Response to Treatment Secondary · 7 days post-dose

The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor.

Very good

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	38
Canakinumab, Lyophilizate (LYO)	33
Triamcinolone Acetonide	32

Good

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	9
Canakinumab, Lyophilizate (LYO)	14
Triamcinolone Acetonide	13

Fair

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	5
Canakinumab, Lyophilizate (LYO)	2
Triamcinolone Acetonide	2

Poor

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	1
Canakinumab, Lyophilizate (LYO)	0
Triamcinolone Acetonide	1

Very poor

Group	Value	95% CI
Canakinumab, Pre-filled Syringes (PFS)	0
Canakinumab, Lyophilizate (LYO)	0
Triamcinolone Acetonide	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Canakinumab, Pre-filled Syringes (PFS)

Serious: 12/133 (9%)

Deaths: 1/133

Canakinumab, Lyophilizate (LYO)

Serious: 7/132 (5%)

Deaths: 0/132

Triamcinolone Acetonide

Serious: 7/132 (5%)

Deaths: 0/132

Serious adverse events (30 terms)

Reaction	System	Canakinumab, Pre-filled Sy…	Canakinumab, Lyophilizate …	Triamcinolone Acetonide
Anaemia	Blood and lymphatic system disorders	—	—	—
Angina unstable	Cardiac disorders	—	—	—
Cardiac failure	Cardiac disorders	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Chest pain	General disorders	—	—	—
Drug ineffective	General disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Respiratory tract infection viral	Infections and infestations	—	—	—
Staphylococcal bacteraemia	Infections and infestations	—	—	—
Viral infection	Infections and infestations	—	—	—
Wound infection staphylococcal	Infections and infestations	—	—	—
Humerus fracture	Injury, poisoning and procedural complications	—	—	—
Muscle rupture	Injury, poisoning and procedural complications	—	—	—
Overdose	Injury, poisoning and procedural complications	—	—	—
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Migraine	Nervous system disorders	—	—	—
Delirium	Psychiatric disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Calculus ureteric	Renal and urinary disorders	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Canakinumab, Pre-filled Sy…	Canakinumab, Lyophilizate …	Triamcinolone Acetonide
Hypertension	Vascular disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—

Most-reported serious reactions: Anaemia, Angina unstable, Cardiac failure, Cardiac failure congestive, Coronary artery disease, Myocardial infarction, Constipation, Chest pain.

Data from ClinicalTrials.gov NCT01431638 adverse events section.

Sponsor's own description

This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Acute Gouty Arthritis

Currently open trials in the same condition.

NCT07453004 — A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With · Phase 2 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

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NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01431638 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 19 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01431638.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing