Trial Outcomes & Findings for Dose Escalation and Remission (DEAR) (NCT NCT00652145)
NCT ID: NCT00652145
Last Updated: 2015-05-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
119 participants
Primary outcome timeframe
6 weeks after randomization
Results posted on
2015-05-05
Participant Flow
We screened 150 patients and enrolled 119 patients with UC in remission on the basis of SCCAI score. 58 patients had baseline fecal calprotectin(FC) \<50 µg/g. These patients were followed in an observational arm. 61 had FC \>= 50 µg/g,whose current mesalamine dose \<3g/day. See preassignment details.
Among 61 pts with FC \>=50 µg/g at week 0, 26 were taking non-MMX mesalamine at baseline and switched to MMX mesalamine 2.4g/day. Of these, by week 6, 2 had a repeat FC \<50 µg/g, 3 had a flare of UC and 4 were noncompliant with study protocol or no longer interested in participating. The remaining 52 patients were included in the randomized trial.
Participant milestones
| Measure |
Increase Dose of Mesalamine
Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
|
Maintain Baseline Mesalamine Dose
Maintain baseline mesalamine dose for six weeks
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Escalation and Remission (DEAR)
Baseline characteristics by cohort
| Measure |
Increase Mesalamine Dose
n=26 Participants
Participants were randomized to increase dose of mesalamine by 2.4 gm per day over their baseline dose
|
Maintain Mesalamine Dose
n=26 Participants
Participants were randomized to maintain their baseline mesalamine dose
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 years
n=99 Participants
|
48.8 years
n=107 Participants
|
46.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
26 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Tobacco use
Current
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Tobacco use
Prior
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Tobacco use
Never
|
20 participants
n=99 Participants
|
16 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Extent of disease
Proctitis
|
8 participants
n=99 Participants
|
2 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Extent of disease
Left-sided
|
9 participants
n=99 Participants
|
12 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Extent of disease
Extensive
|
9 participants
n=99 Participants
|
11 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Extent of disease
Other
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Median duration of UC
|
11.9 years
n=99 Participants
|
6.5 years
n=107 Participants
|
8.9 years
n=206 Participants
|
|
Median of duration of remission at baseline
|
0.3 years
n=99 Participants
|
0.5 years
n=107 Participants
|
0.4 years
n=206 Participants
|
|
Median fecal calprotectin immediately before randomization
|
174 µg/g
n=99 Participants
|
214 µg/g
n=107 Participants
|
195 µg/g
n=206 Participants
|
|
Currrent oral mesalamine
Non-MMX formulation
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Currrent oral mesalamine
MMX formulation
|
14 participants
n=99 Participants
|
12 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Currrent oral mesalamine
None
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Current rectal mesalamine
Yes
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Current rectal mesalamine
No
|
24 participants
n=99 Participants
|
24 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
Current thiopurine
Yes
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Current thiopurine
No
|
20 participants
n=99 Participants
|
22 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Prior corticosteroids
Yes
|
11 participants
n=99 Participants
|
17 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Prior corticosteroids
No
|
15 participants
n=99 Participants
|
9 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Prior rectal corticosteroids
Yes
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Prior rectal corticosteroids
No
|
20 participants
n=99 Participants
|
19 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Prior cyclosporine
Yes
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Prior cyclosporine
No
|
26 participants
n=99 Participants
|
25 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Prior anti-tumor necrosis factor agent
Yes
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Prior anti-tumor necrosis factor agent
No
|
24 participants
n=99 Participants
|
26 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after randomizationOutcome measures
| Measure |
Increase Mesalamine Dose by 2.4g/Day
n=26 Participants
Increase dose of mesalamine by 2.4 gm per day
mesalamine: Increase dose by 2.4gm per day over baseline dose
|
Maintain Mesalmine Dose
n=26 Participants
Maintain current mesalamine dose at 2.4 g/day
|
|---|---|---|
|
Fecal Calprotectin Level <50µg/g
|
7 participants
|
1 participants
|
SECONDARY outcome
Timeframe: at 6 weeks after randomizationPopulation: 38 participants with baseline FC\>=100ug/g
Outcome measures
| Measure |
Increase Mesalamine Dose by 2.4g/Day
n=19 Participants
Increase dose of mesalamine by 2.4 gm per day
mesalamine: Increase dose by 2.4gm per day over baseline dose
|
Maintain Mesalmine Dose
n=19 Participants
Maintain current mesalamine dose at 2.4 g/day
|
|---|---|---|
|
Fecal Calprotectin Level <100 µg/g
|
10 participants
|
3 participants
|
SECONDARY outcome
Timeframe: at 6 weeks after randomizationPopulation: 25 participants with baseline FC\>=200ug/g
Outcome measures
| Measure |
Increase Mesalamine Dose by 2.4g/Day
n=13 Participants
Increase dose of mesalamine by 2.4 gm per day
mesalamine: Increase dose by 2.4gm per day over baseline dose
|
Maintain Mesalmine Dose
n=12 Participants
Maintain current mesalamine dose at 2.4 g/day
|
|---|---|---|
|
Fecal Calprotectin <200 µg/g
|
10 participants
|
2 participants
|
Adverse Events
Increase Dose of Mesalamine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Maintain Baseline Mesalamine Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Increase Dose of Mesalamine
n=26 participants at risk
Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
|
Maintain Baseline Mesalamine Dose
n=26 participants at risk
Maintain baseline mesalamine dose for six weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Skin and subcutaneous tissue disorders
acne
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Gastrointestinal disorders
blood in stool
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
7.7%
2/26 • Number of events 2
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Gastrointestinal disorders
diarrhea
|
11.5%
3/26 • Number of events 3
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Gastrointestinal disorders
Bloating
|
7.7%
2/26 • Number of events 2
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
General disorders
dizziness
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
General disorders
Fatigue
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Infections and infestations
Fever
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Gastrointestinal disorders
Flatulence
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Infections and infestations
Fungal infection
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
General disorders
headache
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Blood and lymphatic system disorders
iron deficiency anemia
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Eye disorders
itchy eyes
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Cardiac disorders
Palpitations
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Infections and infestations
Upper respiratory infection
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
General disorders
Vitamin B12 deficiency
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Gastrointestinal disorders
Worsening Colitis
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
General disorders
Lower back pain
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Gastrointestinal disorders
increase mucous
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
|
Eye disorders
Dry eyes
|
0.00%
0/26
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
3.8%
1/26 • Number of events 1
Participants were asked at each visit if they experienced any new symptoms or whether they were diagnosed with any new medical conditions since their last visit. At each visit, participants were also asked if they had any of the following conditions over the prior 3 days: Erythema nodosum Pyoderma gangrenosum Uveitis IBD-associated arthritis
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place