SHIELD: 38 Week Extension Study to CAIN457C2303
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT01093846
Collaborator
(none)
59
25
3
10.1
2.4
0.2
Study Details
Study Description
Brief Summary
A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 38-week Extension to a 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet's Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy (SHIELD Study)
Study Start Date
:
Mar 1, 2010
Actual Primary Completion Date
:
Jan 1, 2011
Actual Study Completion Date
:
Jan 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AIN457 300 mg every 2 weeks
|
Drug: AIN457
300mg every 2 weeks
|
| Experimental: AIN457 300 mg monthly
|
Drug: AIN457
300mg every 4 weeks
|
| Placebo Comparator: Placebo
|
Drug: Placebo AIN457
Placebo to AIN457
|
Outcome Measures
Primary Outcome Measures
- The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1. [62 weeks]
The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Baltimore | Maryland | United States | 21205-2005 |
| 2 | Novartis Investigative Site | Alexandria | Egypt | ||
| 3 | Novartis Investigative Site | Grenoble | France | 38043 | |
| 4 | Novartis Investigative Site | Heidelberg | Germany | 69120 | |
| 5 | Novartis Investigative Site | Athens | GR | Greece | 115 27 |
| 6 | Novartis Investigative Site | Ioannina | GR | Greece | 455 00 |
| 7 | Novartis Investigative Site | Larissa | GR | Greece | 41110 |
| 8 | Novartis Investigative Site | Patras | Greece | 26500 | |
| 9 | Novartis Investigative Site | Hongkong | Hong Kong | ||
| 10 | Novartis Investigative Site | Ramat Gan | Israel | 52621 | |
| 11 | Novartis Investigative Site | Tel-Aviv | Israel | 64239 | |
| 12 | Novartis Investigative Site | Amman | Jordan | 11195 | |
| 13 | Novartis Investigative Site | Seoul | Korea | Korea, Republic of | 110 744 |
| 14 | Novartis Investigative Site | Seoul | Korea | Korea, Republic of | 120-752 |
| 15 | Novartis Investigative Site | Singapore | Singapore | 308433 | |
| 16 | Novartis Investigative Site | Barcelona | Catalunya | Spain | 08028 |
| 17 | Novartis Investigative Site | Barcelona | Catalunya | Spain | 08035 |
| 18 | Novartis Investigative Site | Lin-Ko | Taiwan | 33305 | |
| 19 | Novartis Investigative Site | Sfax | Tunisia | ||
| 20 | Novartis Investigative Site | Altindag / Ankara | Turkey | 06590 | |
| 21 | Novartis Investigative Site | Ankara | Turkey | 06100 | |
| 22 | Novartis Investigative Site | Ankara | Turkey | 06490 | |
| 23 | Novartis Investigative Site | Fatih / Istanbul | Turkey | 34098 | |
| 24 | Novartis Investigative Site | Istanbul | Turkey | 34093 | |
| 25 | Novartis Investigative Site | Izmir | Turkey | 35380 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01093846
Other Study ID Numbers:
- CAIN457C2303E1
- 2009-013901-33
First Posted:
Mar 26, 2010
Last Update Posted:
Feb 22, 2016
Last Verified:
Jan 1, 2016
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | AIN457 300 mg Every 2 Weeks | AIN457 300 mg Monthly | AIN457 Placebo |
|---|---|---|---|
| Arm/Group Description | 300 mg every two weeks | 300 mg monthly | |
| Period Title: Overall Study | |||
| STARTED | 19 | 18 | 22 |
| COMPLETED | 0 | 0 | 1 |
| NOT COMPLETED | 19 | 18 | 21 |
Baseline Characteristics
| Arm/Group Title | AIN457 300 mg Every 2 Weeks | AIN457 300 mg Monthly | AIN457 Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | 300 mg every two weeks | 300 mg monthly | Total of all reporting groups | |
| Overall Participants | 19 | 18 | 22 | 59 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
36.5
(10.01)
|
36.8
(13.07)
|
34.9
(11.20)
|
36.0
(11.29)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
6
31.6%
|
5
27.8%
|
11
50%
|
22
37.3%
|
| Male |
13
68.4%
|
13
72.2%
|
11
50%
|
37
62.7%
|
Outcome Measures
| Title | The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1. |
|---|---|
| Description | The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section . |
| Time Frame | 62 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Early Termination |
|---|---|
| Arm/Group Description | |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | AIN457 300mg Every 2 Weeks | AIN457 300mg Monthly | Placebo | |||
| Arm/Group Description | AIN457 300mg every 2 weeks. Safety is provided over the entire treatment period. This includes the core and extension period. | AIN457 300mg monthly Safety is provided over the entire treatment period. This includes the core and extension period. | Placebo Safety is provided over the entire treatment period. This includes the core and extension period. | |||
All Cause Mortality |
||||||
| AIN457 300mg Every 2 Weeks | AIN457 300mg Monthly | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| AIN457 300mg Every 2 Weeks | AIN457 300mg Monthly | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/39 (17.9%) | 8/39 (20.5%) | 5/39 (12.8%) | |||
| Cardiac disorders | ||||||
| Supraventricular tachycardia | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Eye disorders | ||||||
| Cataract cortical (Fellow eye) | 0/39 (0%) | 0/39 (0%) | 1/39 (2.6%) | |||
| Cataract nuclear (Fellow eye) | 0/39 (0%) | 0/39 (0%) | 1/39 (2.6%) | |||
| Cataract subcapsular (Fellow eye) | 0/39 (0%) | 0/39 (0%) | 1/39 (2.6%) | |||
| Choroiditis (Fellow eye) | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Glaucoma (Fellow eye) | 0/39 (0%) | 0/39 (0%) | 1/39 (2.6%) | |||
| Retinal infiltrates (Fellow eye) | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Retinal infiltrates (Study eye) | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Uveitis (Fellow eye) | 1/39 (2.6%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Uveitis (Study eye) | 0/39 (0%) | 1/39 (2.6%) | 1/39 (2.6%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Aphthous stomatitis | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Diarrhoea | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Diarrhoea haemorrhagic | 0/39 (0%) | 0/39 (0%) | 1/39 (2.6%) | |||
| Enteritis | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Haematemesis | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Lower gastrointestinal haemorrhage | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| General disorders | ||||||
| Fatigue | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Immune system disorders | ||||||
| Behcet's syndrome | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Behcet's syndrome (Fellow eye) | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Behcet's syndrome (Study eye) | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Infections and infestations | ||||||
| Folliculitis | 2/39 (5.1%) | 0/39 (0%) | 0/39 (0%) | |||
| Hypopyon (Fellow eye) | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Urinary tract infection | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Fall | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Foot fracture | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Investigations | ||||||
| Intraocular pressure increased (Fellow eye) | 0/39 (0%) | 0/39 (0%) | 1/39 (2.6%) | |||
| Weight decreased | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Diabetes mellitus | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Bone pain | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Renal and urinary disorders | ||||||
| Nephrolithiasis | 1/39 (2.6%) | 0/39 (0%) | 0/39 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pulmonary embolism | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Skin lesion | 0/39 (0%) | 1/39 (2.6%) | 0/39 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| AIN457 300mg Every 2 Weeks | AIN457 300mg Monthly | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 28/39 (71.8%) | 27/39 (69.2%) | 25/39 (64.1%) | |||
| Eye disorders | ||||||
| Cataract subcapsular (Fellow eye) | 4/39 (10.3%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Cataract subcapsular (Study eye) | 4/39 (10.3%) | 1/39 (2.6%) | 1/39 (2.6%) | |||
| Eye pain (Study eye) | 1/39 (2.6%) | 2/39 (5.1%) | 2/39 (5.1%) | |||
| Retinal vasculitis (Study eye) | 2/39 (5.1%) | 0/39 (0%) | 1/39 (2.6%) | |||
| Vision blurred (Fellow eye) | 0/39 (0%) | 6/39 (15.4%) | 1/39 (2.6%) | |||
| Vision blurred (Study eye) | 0/39 (0%) | 2/39 (5.1%) | 3/39 (7.7%) | |||
| Visual acuity reduced (Study eye) | 4/39 (10.3%) | 2/39 (5.1%) | 1/39 (2.6%) | |||
| Vitreous floaters (Study eye) | 1/39 (2.6%) | 0/39 (0%) | 2/39 (5.1%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 1/39 (2.6%) | 0/39 (0%) | 2/39 (5.1%) | |||
| Abdominal pain upper | 3/39 (7.7%) | 3/39 (7.7%) | 1/39 (2.6%) | |||
| Aphthous stomatitis | 3/39 (7.7%) | 2/39 (5.1%) | 2/39 (5.1%) | |||
| Diarrhoea | 2/39 (5.1%) | 3/39 (7.7%) | 2/39 (5.1%) | |||
| Mouth ulceration | 0/39 (0%) | 0/39 (0%) | 2/39 (5.1%) | |||
| Nausea | 4/39 (10.3%) | 3/39 (7.7%) | 2/39 (5.1%) | |||
| Toothache | 2/39 (5.1%) | 1/39 (2.6%) | 0/39 (0%) | |||
| Vomiting | 2/39 (5.1%) | 0/39 (0%) | 3/39 (7.7%) | |||
| General disorders | ||||||
| Fatigue | 2/39 (5.1%) | 2/39 (5.1%) | 4/39 (10.3%) | |||
| Non-cardiac chest pain | 2/39 (5.1%) | 0/39 (0%) | 1/39 (2.6%) | |||
| Oedema peripheral | 3/39 (7.7%) | 2/39 (5.1%) | 0/39 (0%) | |||
| Pyrexia | 6/39 (15.4%) | 3/39 (7.7%) | 4/39 (10.3%) | |||
| Infections and infestations | ||||||
| Conjunctivitis infective (Study eye) | 1/39 (2.6%) | 2/39 (5.1%) | 1/39 (2.6%) | |||
| Influenza | 2/39 (5.1%) | 4/39 (10.3%) | 1/39 (2.6%) | |||
| Nasopharyngitis | 2/39 (5.1%) | 2/39 (5.1%) | 1/39 (2.6%) | |||
| Oral herpes | 0/39 (0%) | 0/39 (0%) | 2/39 (5.1%) | |||
| Rash pustular | 2/39 (5.1%) | 0/39 (0%) | 1/39 (2.6%) | |||
| Sinusitis | 0/39 (0%) | 2/39 (5.1%) | 1/39 (2.6%) | |||
| Upper respiratory tract infection | 3/39 (7.7%) | 5/39 (12.8%) | 1/39 (2.6%) | |||
| Urinary tract infection | 1/39 (2.6%) | 1/39 (2.6%) | 2/39 (5.1%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 0/39 (0%) | 0/39 (0%) | 2/39 (5.1%) | |||
| Blood glucose increased | 0/39 (0%) | 2/39 (5.1%) | 0/39 (0%) | |||
| Intraocular pressure increased (Study eye) | 2/39 (5.1%) | 3/39 (7.7%) | 0/39 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 4/39 (10.3%) | 3/39 (7.7%) | 3/39 (7.7%) | |||
| Pain in extremity | 3/39 (7.7%) | 1/39 (2.6%) | 2/39 (5.1%) | |||
| Nervous system disorders | ||||||
| Dizziness | 0/39 (0%) | 3/39 (7.7%) | 0/39 (0%) | |||
| Headache | 9/39 (23.1%) | 7/39 (17.9%) | 10/39 (25.6%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 0/39 (0%) | 3/39 (7.7%) | 0/39 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 2/39 (5.1%) | 0/39 (0%) | 0/39 (0%) | |||
| Oropharyngeal pain | 0/39 (0%) | 2/39 (5.1%) | 2/39 (5.1%) | |||
| Rhinorrhoea | 0/39 (0%) | 1/39 (2.6%) | 2/39 (5.1%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Acne | 1/39 (2.6%) | 0/39 (0%) | 2/39 (5.1%) | |||
| Erythema | 1/39 (2.6%) | 1/39 (2.6%) | 2/39 (5.1%) | |||
| Hirsutism | 2/39 (5.1%) | 0/39 (0%) | 1/39 (2.6%) | |||
| Skin lesion | 1/39 (2.6%) | 0/39 (0%) | 2/39 (5.1%) | |||
| Vascular disorders | ||||||
| Hypertension | 1/39 (2.6%) | 2/39 (5.1%) | 1/39 (2.6%) | |||
Limitations/Caveats
Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses were reduced to summary of AEs occurred during the extension and safety follow-up periods.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01093846
Other Study ID Numbers:
- CAIN457C2303E1
- 2009-013901-33
First Posted:
Mar 26, 2010
Last Update Posted:
Feb 22, 2016
Last Verified:
Jan 1, 2016