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Trial record 1 of 1 for:    29343509 [PUBMED-IDS]
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Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis (986)

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ClinicalTrials.gov Identifier: NCT01999192
Recruitment Status : Terminated (Lack of efficacy)
First Posted : December 3, 2013
Results First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biotest

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Tregalizumab
Drug: Placebo
Enrollment 321
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 Tregalizumab Dose Level 2 Tregalizumab Dose Level 3 Tregalizumab Placebo
Hide Arm/Group Description 25mg Tregalizumab s.c. weekly 100mg Tregalizumab s.c. weekly 200mg Tregalizumab s.c. weekly Placebo s.c. weekly
Period Title: Main Phase I
Started 83 80 78 80
Completed 72 70 70 72
Not Completed 11 10 8 8
Period Title: Main Phase II
Started 64 [1] 75 [2] 98 [2] 44 [3]
Completed 55 66 76 43
Not Completed 9 9 22 1
[1]
Non-responders were switched to higher dose Level after Main Phase 1, started = completed -switched.
[2]
started Patient = completed patients + switched patients (non-responder) from other arms.
[3]
non-responders were switched to higher dose Level after Main Phase 1, started = completed -switched
Period Title: Extension Phase
Started 54 [1] 56 [1] 68 [2] 0 [3]
Completed 41 38 44 0
Not Completed 13 18 24 0
[1]
Some patients terminated or were switched to higher dose Level after Main Phase 2.
[2]
Some patients terminated after Main Phase 2.
[3]
No Placebo arm for Extension Phase, all patients terminated or were switched to tregalizumab Groups.
Arm/Group Title Dose Level 1 Tregalizumab Dose Level 2 Tregalizumab Dose Level 3 Tregalizumab Placebo Total
Hide Arm/Group Description 25mg Tregalizumab s.c. weekly 100mg Tregalizumab s.c. weekly 200mg Tregalizumab s.c. weekly Placebo s.c. weekly Total of all reporting groups
Overall Number of Baseline Participants 80 78 76 79 313
Hide Baseline Analysis Population Description
8 subjects of 321 who had no post-baseline assessment were excluded from the Full Analysis Set (FAS), (one subject [1.3%] in the placebo group, three subjects [3.6%] in Dose Level 1 Tregalizumab group, two subjects [2.5%] in Dose Level 2 Tregalizumab group, and two subjects [2.6%] in Dose Level 3 Tregalizumab group).
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 80 participants 78 participants 76 participants 79 participants 313 participants
0-<40 years 9 19 12 10 50
40-<=65 years 62 56 56 57 231
>65 years 9 3 8 12 32
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 78 participants 76 participants 79 participants 313 participants
Female
71
  88.8%
68
  87.2%
58
  76.3%
66
  83.5%
263
  84.0%
Male
9
  11.3%
10
  12.8%
18
  23.7%
13
  16.5%
50
  16.0%
1.Primary Outcome
Title The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX
Hide Description

The primary efficacy variable was the proportion of subjects with an ACR20 response after 12 weeks of double-blind treatment with the study medication.

The analysis of the primary endpoint was performed using observed cases (OC) on the FAS.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

The analysis of the primary endpoint was performed using observed cases (OC) on the FAS.

Full analysis set (FAS): All subjects entered into the study who received at least one dose of study medication and have at least one post-baseline assessment.

Arm/Group Title Dose Level 1 Tregalizumab Dose Level 2 Tregalizumab Dose Level 3 Tregalizumab Placebo
Hide Arm/Group Description:
25mg Tregalizumab s.c. weekly
100mg Tregalizumab s.c. weekly
200mg Tregalizumab s.c. weekly
Placebo s.c. weekly
Overall Number of Participants Analyzed 71 66 70 71
Measure Type: Number
Unit of Measure: percentage of Subjects
42.3 47.0 44.3 35.2
2.Secondary Outcome
Title Proportions of Subjects With an ACR 20 Response.
Hide Description [Not Specified]
Time Frame Week 24
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Proportions of Subjects With an ACR 50 & 70 Response.
Hide Description [Not Specified]
Time Frame Week 12 & Week 24
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Proportions of Subjects With an Disease Activity Score DAS28 <2.6
Hide Description [Not Specified]
Time Frame Week 12 & Week 24
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Proportions of Subjects With Low Disease Activity DAS28 ≤3.2
Hide Description [Not Specified]
Time Frame Week 12 & Week 24
Outcome Measure Data Not Reported
6.Secondary Outcome
Title ACR Score
Hide Description [Not Specified]
Time Frame up to 48 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Simple Disease Activity Index [SDAI] ≤11
Hide Description [Not Specified]
Time Frame week 12 & 24
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Clinical Disease Activity Index [CDAI] ≤10
Hide Description [Not Specified]
Time Frame week 12 & 24
Outcome Measure Data Not Reported
9.Secondary Outcome
Title DAS28
Hide Description [Not Specified]
Time Frame up to 48 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title EULAR Response
Hide Description [Not Specified]
Time Frame up to 48 weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title ACR Score Individual Components
Hide Description [Not Specified]
Time Frame up to 48 weeks
Outcome Measure Data Not Reported
12.Secondary Outcome
Title DAS28 Score Individual Components
Hide Description [Not Specified]
Time Frame up to 48 weeks
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Pharmacokinetics
Hide Description AUC, Cmax, Tmax at baseline, and at Week (W) 2/Visit (V) 4, W4/V5, W8/V7, W12/V8, W24/V10, W3/V122, W48 (end of Treatment [EoT]/ early termination ET), and at follow-up (post EoT/post ET).
Time Frame up to 48 weeks
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Evaluation of Safety, Patient Reported Outcomes & Blood Tests.
Hide Description [Not Specified]
Time Frame up to 48 weeks
Outcome Measure Data Not Reported
Time Frame through study completion, up to 1 year
Adverse Event Reporting Description All adverse events have been matched in accordance with the dosing under which they occurred. This resulted in a higher number of subjects at risk, because some subjects received two dosages. Patients who responded at week 12 continued the same treatment for 12 weeks and non-responders at week 12 were escalated to the next higher dose level or re-randomized to active treatment (placebo patients). After 24 weeks, placebo patients were switched to active treatment during the Extension Phase.
 
Arm/Group Title 25mg Dose Level 1 Tregalizumab 100mg Dose Level 2 Tregalizumab 200mg Dose Level 3 Tregalizumab Placebo
Hide Arm/Group Description Dose Level 1 Tregalizumab (25mg) Dose Level 2 Tregalizumab (100mg) Dose Level 3 Tregalizumab (200mg) Placebo -
All-Cause Mortality
25mg Dose Level 1 Tregalizumab 100mg Dose Level 2 Tregalizumab 200mg Dose Level 3 Tregalizumab Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
25mg Dose Level 1 Tregalizumab 100mg Dose Level 2 Tregalizumab 200mg Dose Level 3 Tregalizumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/105 (2.86%)      1/117 (0.85%)      7/122 (5.74%)      1/80 (1.25%)    
Cardiac disorders         
Acute Coronary Syndrome  1  1/105 (0.95%)  1 0/117 (0.00%)  0 0/122 (0.00%)  0 0/80 (0.00%)  0
Gastrointestinal disorders         
Abdominal Hernia  1  0/105 (0.00%)  0 0/117 (0.00%)  0 1/122 (0.82%)  1 0/80 (0.00%)  0
Colitis  1  1/105 (0.95%)  1 0/117 (0.00%)  0 0/122 (0.00%)  0 0/80 (0.00%)  0
General disorders         
Death  1  0/105 (0.00%)  0 0/117 (0.00%)  0 1/122 (0.82%)  1 0/80 (0.00%)  0
Infections and infestations         
Gangrene  1  0/105 (0.00%)  0 0/117 (0.00%)  0 1/122 (0.82%)  1 0/80 (0.00%)  0
Peritonitis  1  1/105 (0.95%)  1 0/117 (0.00%)  0 0/122 (0.00%)  0 0/80 (0.00%)  0
Injury, poisoning and procedural complications         
Multiple Injuries  1  0/105 (0.00%)  0 1/117 (0.85%)  1 0/122 (0.00%)  0 0/80 (0.00%)  0
Road Traffic Accident  1  0/105 (0.00%)  0 1/117 (0.85%)  1 0/122 (0.00%)  0 0/80 (0.00%)  0
Frostbite  1  0/105 (0.00%)  0 0/117 (0.00%)  0 1/122 (0.82%)  1 0/80 (0.00%)  0
Investigations         
Flavivirus Test Positive  1  0/105 (0.00%)  0 0/117 (0.00%)  0 0/122 (0.00%)  0 1/80 (1.25%)  1
Musculoskeletal and connective tissue disorders         
Osteoarthritis  1  1/105 (0.95%)  1 0/117 (0.00%)  0 0/122 (0.00%)  0 0/80 (0.00%)  0
Nervous system disorders         
Multiple Sclerosis  1  0/105 (0.00%)  0 0/117 (0.00%)  0 0/122 (0.00%)  0 1/80 (1.25%)  1
Cerebral Haemorrhage  1  0/105 (0.00%)  0 0/117 (0.00%)  0 1/122 (0.82%)  1 0/80 (0.00%)  0
Generalised Tonic-Clonic Seizure  1  0/105 (0.00%)  0 0/117 (0.00%)  0 1/122 (0.82%)  1 0/80 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis  1  0/105 (0.00%)  0 0/117 (0.00%)  0 1/122 (0.82%)  1 0/80 (0.00%)  0
Skin and subcutaneous tissue disorders         
Lichen Planus  1  0/105 (0.00%)  0 0/117 (0.00%)  0 1/122 (0.82%)  1 0/80 (0.00%)  0
Vascular disorders         
Shock Haemorrhagic  1  0/105 (0.00%)  0 1/117 (0.85%)  1 0/122 (0.00%)  0 0/80 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
25mg Dose Level 1 Tregalizumab 100mg Dose Level 2 Tregalizumab 200mg Dose Level 3 Tregalizumab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/105 (13.33%)      16/117 (13.68%)      15/122 (12.30%)      9/80 (11.25%)    
Infections and infestations         
Nasopharyngitis  1  7/105 (6.67%)  9 6/117 (5.13%)  7 7/122 (5.74%)  10 4/80 (5.00%)  4
Musculoskeletal and connective tissue disorders         
Rheumatoid Arthritis  1  5/105 (4.76%)  5 6/117 (5.13%)  6 5/122 (4.10%)  5 2/80 (2.50%)  3
Nervous system disorders         
Headache  1  3/105 (2.86%)  4 6/117 (5.13%)  9 6/122 (4.92%)  6 3/80 (3.75%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Due to the lack of efficacy the Extension Phase of the study was terminated early.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Xuefei Zhou Manager Strategy & Development
Organization: Biotest AG
Phone: +496103801 ext 1229
Responsible Party: Biotest
ClinicalTrials.gov Identifier: NCT01999192     History of Changes
Other Study ID Numbers: 986_TREAT 2b
2013-000114-38 ( EudraCT Number )
BT986 ( Other Identifier: Biotest AG )
First Submitted: November 17, 2013
First Posted: December 3, 2013
Results First Submitted: March 16, 2017
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017